Clinical Trials Using Capecitabine

Clinical trials are research studies that involve people. The clinical trials on this list are studying Capecitabine. 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 78
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  • Lower-Dose Chemoradiation in Treating Patients with Early-Stage Anal Cancer, the DECREASE Study

    This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.
    Location: 513 locations

  • Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients with Esophageal and Gastric Cancer that has Spread to a Limited Number of Other Places in the Body

    This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine, 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. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer.
    Location: 367 locations

  • Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

    This trial studies how well proton beam radiation therapy compared with intensity modulated photo radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photo radiotherapy will work better in treating patients with esophageal cancer.
    Location: 53 locations

  • Circulating Tumor DNA Testing in Predicting Treatment for Patients with Stage IIA Colon Cancer After Surgery, COBRA Trial

    This phase II / III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works to identify patients with stage IIA colon cancer who might benefit from additional treatment with chemotherapy after surgery. ctDNA are small pieces of genetic materials (DNA) that are shed by tumors into the blood. Finding ctDNA in the blood means that there are very likely small amounts of cancer remaining after surgery that may not be detectable using other tests, such as medical imaging. Testing for ctDNA levels may help identify patients with colon cancer who benefit from receiving chemotherapy after surgery. It is not yet known whether giving additional treatment with chemotherapy after surgery to patients who test positive for ctDNA and are at low risk for cancer recurrence would extend their time without disease compared to the usual approach (active surveillance).
    Location: 684 locations

  • Capecitabine in Treating Patients with Metastatic Breast Cancer or Advanced / Metastatic Gastrointestinal Cancers

    This randomized phase II trial studies the side effects of capecitabine and how well it works when it is given dose-dense, fixed-dose as compared to standard dose in treating patients with breast cancer or gastrointestinal cancer that has spread from where it started to other places in the body or gastrointestinal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as capecitabine, 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.
    Location: 15 locations

  • Study of IMMU-132 in HR+ / HER2- MBC (TROPICS-02)

    This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+ / HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.
    Location: 14 locations

  • Neratinib, Capecitabine, and Trastuzumab Emtansine in Treating Patients with HER2-Positive Breast Cancer That Has Spread to the Brain

    This phase II trial studies how well neratinib, capecitabine, and trastuzumab emtansine work in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to the brain. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine, 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. Trastuzumab emtansine (T-DM1) is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Giving neratinib, capecitabine, and trastuzumab emtansine together may be an effective treatment for breast cancer.
    Location: 14 locations

  • A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer

    A Phase 2a, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
    Location: 14 locations

  • Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2 / 3 Trial in HER2+ Gastric / GEJ Cancer (MAHOGANY)

    This is a Phase 2 / 3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer to determine the efficacy of margetuximab combined with INCMGA00012 (also known as MGA012) (Cohort A) and margetuximab combined with INCMGA00012 or MGD013 and chemotherapy compared to trastuzumab combined with chemotherapy (Cohort B).
    Location: 16 locations

  • Tucatinib, Trastuzumab, and Capecitabine in Treating Patients with HER2 Positive Breast Cancer with Leptomeningeal Metastases

    This phase II trial studies how well tucatinib, trastuzumab, and capecitabine work in treating patients with HER2 positive breast cancer that has spread to the leptomeninges (leptomeningeal metastases). Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. Drugs used in chemotherapy, such as capecitabine, 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 tucatinib, trastuzumab, and capecitabine may help to control leptomeningeal disease and improve survival in patients with breast cancer.
    Location: 11 locations

  • Capecitabine and Neratinib in Treating Patients with HER2 Positive Stage IV Breast Cancer

    This phase Ib / II trial studies the side effects and best dose of capecitabine when given together with neratinib and to see how well it works in treating patients with HER2 positive stage IV breast cancer. Drugs used in chemotherapy, such as capecitabine, 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. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and neratinib may work better than capecitabine alone in treating patients with breast cancer.
    Location: 9 locations

  • Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

    The study is a multi-center, un-blinded, randomized control study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.
    Location: 10 locations

  • Lenvatinib (E7080 / MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009 / E7080-G000-228 / LEAP-009)

    This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent / metastatic head and neck squamous cell carcinoma (R / M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that pembrolizumab + lenvatinib is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.
    Location: 12 locations

  • Pembrolizumab / Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811 / KEYNOTE-811)

    The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).
    Location: 8 locations

  • Dostarlimab before Chemoradiotherapy and Surgery for the Treatment of Locally Advanced Mismatch Repair Deficiency or Microsatellite Instability Rectal Cancer

    This phase II trial studies how well dostarlimab (TSR-042) before standard chemoradiotherapy and surgery works in treating patients with mismatch repair deficiency or microsatellite instability rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Dostarlimab is a type of medication called an antibody, which is a protein made by the immune system to protect the body from harm. Dostarlimab blocks another protein (programmed cell death receptor-1, or PD-1) that usually acts as a “brake” on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target tumor cells and kill them.
    Location: 7 locations

  • Hypofractionated Ablative Intensity-Modulated Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients with Potentially Resectable Locally Advanced Pancreatic Cancer

    This phase II trial studies how well hypofractionated ablative intensity-modulated radiation therapy and capecitabine or fluorouracil work in treating patients with pancreatic cancer that has spread from its original site of growth to nearby tissues or lymph nodes and may be able to be removed by surgery. 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. Drugs used in chemotherapy, such as capecitabine and fluorouracil, 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 hypofractionated ablative intensity-modulated radiation therapy and capecitabine or fluorouracil may work better in treating patients with pancreatic cancer.
    Location: 7 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 and CAPOX). 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. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).
    Location: 8 locations

  • A Randomized Phase 2 / 3 Multi-Center Study of SM-88 in Patients With Metastatic Pancreatic Cancer

    A prospective, open-label phase 2 / 3 trial in metastatic pancreatic cancer subjects who have failed two lines of prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. (Part 1 enrollment complete) In the initial stage of the trial (36 subjects), two dose levels of SM-88's metyrosine-derivative was evaluated. (Part 2 actively enrolling) The second part will consist of a subsequent expansion of the trial to further assess safety and efficacy of SM-88 used with MPS containing the selected SM-88 RP2D from Part 1. A total of 250 subjects in the second part will be randomized 1:1 either to the SM-88 arm (125 subjects) or Physician's Choice of therapy for the Control Arm (125 subjects). Subjects should have previously received two lines of prior systemic therapy.
    Location: 7 locations

  • Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

    This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and / or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK).
    Location: 6 locations

  • High-Dose-Rate Brachytherapy and Chemotherapy in Treating Patients with Locally Recurrent or Residual Rectal or Anal Cancer Undergoing Non-operative Management

    This phase I trial studies the side effects and best dose of high-dose-rate brachytherapy when given together with chemotherapy in treating patients with rectal or anal cancer that has come back or gotten worse and cannot be treated with surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. High-dose-rate (HDR) brachytherapy uses the radioactive material to deliver a high radiation dose in a short period of time to the tumor. It may also send less radiation to nearby healthy tissues and may reduce the risk of side effects. Drugs used in chemotherapy, such as capecitabine and fluorouracil, 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 HDR brachytherapy together with capecitabine or fluorouracil may kill more tumor cells.
    Location: 6 locations

  • A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastroesophageal Adenocarcinoma

    This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus physician's choice of combination chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (GEA). Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA.
    Location: 5 locations

  • Study of Peposertib in Combination With Capecitabine and Radiotherapy in Rectal Cancer

    The main purpose of the study is to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) of Peposertib in combination with capecitabine and radiotherapy (RT) in Phase Ib and to evaluate the efficacy of Peposertib in terms of Pathological Clinical Response (pCR) / Clinical Complete Response (cCR) when administered in combination with capecitabine and RT versus placebo, capecitabine, and RT in Phase II.
    Location: 7 locations

  • Study of Adagloxad Simolenin (OBI-822) / OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC

    The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822) / OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.
    Location: 5 locations

  • Nivolumab and Capecitabine in Treating Patients with Triple Negative Breast Cancer with Residual Cancer Burden

    This phase II trial studies how well nivolumab and capecitabine work in treating patients with triple negative breast cancer with residual cancer burden and to assess whether a test in a patient’s blood can be used to predict who may benefit from further treatment with immunotherapy following standard primary chemotherapy for triple negative breast cancer. 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 capecitabine, 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 yet known whether nivolumab or capecitabine work better in treating patients with triple negative breast cancer.
    Location: 5 locations

  • Docetaxel and Capecitabine in Treating Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

    This phase II trial studies the side effects and how well docetaxel and capecitabine work in treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that has come back or spread to other places in the body. Drugs used in chemotherapy, such as docetaxel and capecitabine, 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.
    Location: 5 locations


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