Treatment Clinical Trials for Gallbladder Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for gallbladder cancer treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 34
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  • Nivolumab and Ipilimumab in Treating Patients with Rare Tumors

    This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07 / 27 / 2018) 2. Epithelial tumors of major salivary glands (closed to accrual 03 / 20 / 2018) 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) 4. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. Adenocarcinoma with variants of small intestine (closed to accrual 05 / 10 / 2018) 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10 / 17 / 2018) 7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03 / 20 / 2018) 8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible 9. Intrahepatic cholangiocarcinoma (closed to accrual 03 / 20 / 2018) 10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03 / 20 / 2018) 11. Sarcomatoid carcinoma of lung 12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma 13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03 / 30 / 2018) 14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual) 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual) 16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non-seminomatous tumor C) Teratoma with malignant transformation (closed to accrual) 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 18. Squamous cell carcinoma variants of the genitourinary (GU) system 19. Spindle cell carcinoma of kidney, pelvis, ureter 20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07 / 27 / 2018) 21. Odontogenic malignant tumors 22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual) 23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12 / 19 / 2017) 24. Pheochromocytoma, malignant (closed to accrual) 25. Paraganglioma (closed to accrual 11 / 29 / 2018) 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual) 27. Desmoid tumors 28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09 / 19 / 2018) 29. Malignant giant cell tumors 30. Chordoma (closed to accrual 11 / 29 / 2018) 31. Adrenal cortical tumors (closed to accrual 06 / 27 / 2018) 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12 / 22 / 2017) 33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03 / 15 / 2019) 34. Adenoid cystic carcinoma (closed to accrual 02 / 06 / 2018) 35. Vulvar cancer (temporarily closed to accrual) 36. MetaPLASTIC carcinoma (of the breast) (closed to accrual) 37. Gastrointestinal stromal tumor (GIST) (closed to accrual 09 / 26 / 2018) 38. Perivascular epithelioid cell tumor (PEComa) 39. Apocrine tumors / extramammary Paget’s disease (closed to accrual) 40. Peritoneal mesothelioma (temporarily closed to accrual 05 / 08 / 2020) 41. Basal cell carcinoma (temporarily closed to accrual 04 / 29 / 2020) 42. Clear cell cervical cancer 43. Esthenioneuroblastoma (closed to accrual) 44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual) 45. Clear cell ovarian cancer (closed to accrual) 46. Gestational trophoblastic disease (GTD) 47. Gallbladder cancer 48. Small cell carcinoma of the ovary, hypercalcemic type 49. PD-L1 amplified tumors 50. Angiosarcoma 51. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 52). Small cell lung cancer is not eligible (temporarily closed to accrual 03 / 25 / 2020) 52. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)
    Location: 893 locations

  • Gemcitabine Hydrochloride and Cisplatin with or without Nab-Paclitaxel in Treating Patients with Newly Diagnosed Advanced Biliary Tract Cancers

    This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body (advanced). Chemotherapy drugs, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
    Location: 681 locations

  • Pembrolizumab (MK-3475) Plus Gemcitabine / Cisplatin Versus Placebo Plus Gemcitabine / Cisplatin for First-Line Advanced and / or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966 / KEYNOTE-966)

    This is a study of pembrolizumab plus gemcitabine / cisplatin versus placebo plus gemcitabine / cisplatin as first-line therapy in participants with advanced and / or unresectable biliary tract carcinoma. The study has 2 primary hypotheses: 1. Pembrolizumab plus gemcitabine / cisplatin is superior to placebo plus gemcitabine / cisplatin with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) and 2. Pembrolizumab plus gemcitabine / cisplatin is superior to placebo plus gemcitabine / cisplatin with respect to overall survival (OS).
    Location: 11 locations

  • Durvalumab or Placebo in Combination With Gemcitabine / Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

    Durvalumab or Placebo in Combination With Gemcitabine / Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
    Location: 8 locations

  • A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer

    A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
    Location: 7 locations

  • Gemcitabine Hydrochloride, Cisplatin, and Nivolumab in Treating Patients with Muscle-Invasive Bladder Cancer

    This phase II trial studies the side effects of gemcitabine hydrochloride, cisplatin, and nivolumab and to see how well they work in treating patients with muscle-invasive bladder cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving gemcitabine hydrochloride, cisplatin, and nivolumab may work better in treating patients with muscle-invasive bladder cancer.
    Location: 7 locations

  • Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)

    Study consists of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2 / 3 part. In the Phase 2 / 3 part, the study will evaluate whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.
    Location: 6 locations

  • Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080 / MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005 / E7080-G000-224 / LEAP-005)

    The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080 / MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), or biliary tract cancers (BTC). Participants will be enrolled into initial tumor-specific cohorts which will be expanded if adequate efficacy is determined.
    Location: 5 locations

  • Guadecitabine and Durvalumab in Treating Patients with Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer

    This phase Ib trial studies the side effects and best dose of guadecitabine and how well it works when given together with durvalumab in treating patients with liver, pancreatic, bile duct, or gallbladder cancer that has spread to other places in the body. Guadecitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with durvalumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving guadecitabine and durvalumab may work better in treating patients with liver, pancreatic, bile duct, or gallbladder cancer.
    Location: 4 locations

  • Testing the Combination of New Anti-cancer Drug Nedisertib with Avelumab and Radiation Therapy for Advanced / Metastatic Solid Tumors and Hepatobiliary Malignancies

    This phase I / II trial studies the best dose and side effects of nedisertib and to see how well it works with avelumab and hypofractionated radiation therapy in treating patients with solid tumors and hepatobiliary malignancies that have spread to other places in the body (advanced / metastatic). Nedisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving nedisertib in combination with avelumab and hypofractionated radiation therapy may work better than other standard chemotherapy, hormonal, targeted, or immunotherapy medicines available in treating patients with solid tumors and hepatobiliary malignancies.
    Location: 3 locations

  • DKN-01 and Nivolumab for the Treatment of Advanced Biliary Tract Cancer

    This phase II trial studies how well DKN-01 and nivolumab work in treating patients with biliary tract cancer that has spread to other places in the body (advanced). DKN-01 and nivolumab are both antibodies. An antibody is a protein that attaches to other cells to fight off infection. DKN-01 may work by attaching to and inhibiting (stopping) a specific pathway in your cells that is responsible for processes such as cell growth. Nivolumab may work by attaching to and inhibiting a specific protein in your cancer that controls parts of your immune system (the system in your body that fights off infections and diseases) by shutting down certain immune responses. Nivolumab may inhibit the protein, thus allowing immune cells to recognize and destroy cancer cells. Giving DKN-01 and nivolumab may work better in treating patients with advanced biliary tract cancer.
    Location: 3 locations

  • Rucaparib and Nivolumab in Treating Patients with Advanced or Metastatic Biliary Tract Cancer after Platinum Therapy

    This phase II trial studies how well rucaparib and nivolumab work in treating patients with biliary tract cancer that has spread to other places in the body after platinum therapy. Rucaparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving rucaparib and nivolumab after platinum therapy may help kill more cancer cells that are left after chemotherapy.
    Location: 3 locations

  • Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers

    This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (FOLFOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).
    Location: 5 locations

  • Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

    NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: - The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care - The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care
    Location: 4 locations

  • Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan for the Treatment of Previously Treated Advanced Biliary Tract Cancer, NAPOLI-2 Study

    This phase II trial studies how well fluorouracil, leucovorin, and nanoliposomal irinotecan work in treating patients with previously treated biliary tract cancer that has spread to other places in the body (advanced). Fluorouracil is a chemotherapy drug that works by blocking the ability of tumor cells to grow and divide. Leucovorin is a vitamin that allows fluorouracil to work more effectively by increasing the time the active product of fluorouracil is in contact with its target. Nanoliposomal irinotecan is a new formulation of irinotecan, a chemotherapy drug that kills rapidly dividing cells and blocks the ability of tumor cells to grow and divide. Giving fluorouracil, leucovorin, and nanoliposomal irinotecan may work better in treating patients with biliary tract cancer compared to fluorouracil and leucovorin.
    Location: 3 locations

  • Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer

    Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian / endometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian / endometrial tumors to shrink and to see if this treatment is safe. Eligibility: - Adults age 18-70 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian / endometrial cancer, or glioblastoma refractory to standard chemotherapy. Design: Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.
    Location: 2 locations

  • CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors

    This is a multicenter, open-label, phase 1b study of CBP501 / cisplatin / nivolumab combination administered once every 21 days to patients with advanced solid tumors.
    Location: 2 locations

  • Personalized Cancer Therapy in Treating Participants with Metastatic or Unresectable Cancers

    This pilot trial studies how well personalized cancer therapy works in treating participants with cancer that has spread to other places in the body or cannot be removed by surgery. Personalized cancer therapy is the practice of making decisions about what kind of treatment participants should receive based on the genetic makeup of the tumor. Genes in your body encode certain characteristics such as height, eye and hair color. Researchers believe that abnormal genes in tumors may affect how individuals respond to cancer treatments. Collecting information about tests and treatments received will help researchers describe if patients respond better when their physicians choose to treat them according to the genetic makeup of their tumor.
    Location: 2 locations

  • A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

    This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
    Location: 5 locations

  • Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel

    Background: People with rare cancers often have limited treatment options. The biology of rare cancers is not well understood. Researchers want to find better treatments for these cancers. They want to test 2 drugs that, taken separately, have helped people with non-rare cancers. They want to see if these drugs together can make rare cancers shrink or stop growing. Objective: To learn if nilotinib and paclitaxel will benefit people with rare cancers. Eligibility: People age 18 and older who have a rare, advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists. Design: Participants will be screened with medical history and physical exam. They will have blood and urine tests. They will have a pregnancy test if needed. They will have an electrocardiogram to check their heart. They will have imaging scans to measure their tumors. Participants will repeat the screening tests during the study. Participants will receive nilotinib and paclitaxel. The drugs are given in 28-day cycles. Nilotinib is a capsule taken by mouth twice a day. Paclitaxel will be given intravenously by peripheral line or central line once a week for the first 3 weeks of each cycle. Participants will keep a medicine diary. They will track when they take the study drugs and any side effects they may have. Participants may have optional tumor biopsies. Participants can stay on the study until their disease gets worse or they have intolerable side effects. Participants will have a follow-up phone call about 30 days after taking the last dose of study drugs.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Gemcitabine and Cisplatin with or without Devimistat as First Line Therapy for the Treatment of Advanced Unresectable Biliary Tract Cancer, BilT-04 Trial

    This phase IB / II trial investigates the side effects and best dose of devimistat and how well it works with gemcitabine and cisplatin as initial treatment (first-line therapy) for patients with biliary tract cancer that has spread to other places in the body (advanced) or cannot be removed by surgery (unresectable). Devimistat may kill tumor cells by turning off their mitochondria. Mitochondria are used by tumor cells to produce energy and are the building blocks needed to make more tumor cells. By shutting off these mitochondria, devimistat may deprive the tumor cells of energy and other supplies that they need to survive and grow in the body. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving devimistat with gemcitabine and cisplatin may kill more tumor cells than giving only gemcitabine and cisplatin.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • Ulixertinib and Hydroxychloroquine for the Treatment of Advanced MAPK-Mutated Gastrointestinal Cancers

    This phase I trial identifies side effects, activity, and best dose of ulixertinib when given together with hydroxychloroquine in treating patients with MAPK gene mutated gastrointestinal cancer that has spread to other places in the body (advanced). MAP kinase (MAPK) gene products are involved in a wide variety of cellular processes such as proliferation and differentiation. Ulixertinib may stop the growth of tumor cells by blocking some of the MAPK gene products needed for cell growth. Hydroxychloroquine is used to decrease the body's immune response and may result in tumor cell death. Giving ulixertinib and hydroxychloroquine may shrink tumors in patients with gastrointestinal cancer.
    Location: Huntsman Cancer Institute / University of Utah, Salt Lake City, Utah

  • Trifluridine / Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer

    This phase II trial studies how well trifluridine / tipiracil and irinotecan work in treating patients with biliary tract cancer that has spread to other places in the body (advanced) and has not responded to treatment (refractory). Trifluridine / tipiracil and irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • Nivolumab, Nal-Irinotecan, Fluorouracil, and Leucovorin as Second Line Therapy in Treating Patients with Advanced Biliary Tract Cancer

    This phase Ib / II trial studies the side effects of nivolumab, nal-irinotecan, fluorouracil, and leucovorin and to see how well they work in treating patients with biliary tract cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as nal-irinotecan, 5-fluorouracil, and leucovorin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with chemotherapy (nal-irinotecan, 5-fluorouracil, and leucovorin) may work better in treating patients with biliary tract cancer compared to chemotherapy alone.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients

    This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity. The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal or liver cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients.
    Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas


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