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Rectal Cancer clinical trials at UC Cancer

10 research studies open to eligible people

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  • A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

    open to eligible people ages 18 years and up

    This is a first in human, multicenter, open label, Phase 1a/b dose escalation and dose expansion study to establish the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose escalating fashion in subjects with advanced solid tumors. Up to 36 subjects will be enrolled into the Phase 1a dose escalation part of the study. Every effort will be made to ensure approximately 50% of all subjects enrolled in this study will be subjects with the tumors of special interest such as squamous cell carcinoma of the head and neck (SCCHN), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and transitional cell carcinoma of the bladder (TCC). Subjects with other solid tumor types are also eligible provided study selection criteria are met and they do not exceed 50% of all enrolled subjects. The study will be conducted in the United States at approximately 3 to 5 sites. This Phase 1a/b study will follow a traditional 3+3 design. The starting dose level will be 10 mg QD, escalating to 20, 40, 75, 125, and 150 mg QD as safety allows. All doses are to be administered in the fasting state with water at least 1 hour before food or at least 2 hours after food. The Phase 1b dose expansion part will involve cohort expansion at up to 2 dose levels selected from the dose escalation data by the safety monitoring committee (SMC), to obtain additional safety and preliminary efficacy information. Each cohort in Phase 1b will enroll 15 subjects. The study will be expanded into a Phase 2 study via protocol amendment which will then assess the dose and tumor type(s) selected in Phase 1a/b as the most appropriate for further clinical development. Subjects will be dosed until unacceptable toxicity, disease progression per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST), discontinuation of treatment for other protocol allowed reason (eg, subject refusal), any other administrative reasons, or after 2 years of treatment, whichever occurs first. For scheduling purposes, dosing will occur in 3 week cycles and computed tomography (CT) scans will be conducted once every 6 weeks with the first postbaseline scan after 6 weeks of dosing (precycle 3).

    at UCSD

  • Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery

    open to eligible people ages 18 years and up

    Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.

    at UCSF

  • Improving Nutrition and Physical Activity for Colorectal Cancer Survivors (Tools To Be Fit)

    open to eligible people ages 18 years and up

    This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in colorectal cancer survivors. Studies indicate that people with colorectal cancer whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition and Physical Activity Guidelines may have longer disease-free survival. The four different intervention components may help patients with colon or rectal cancer adopt recommended health behaviors after they have completed treatment.

    at UCSF

  • Phase 2 Study of DKN-01 in Colorectal Cancer

    open to eligible people ages 18 years and up

    This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of care (SOC) [FOLFIRI/FOLFOX and bevacizumab] as second-line treatment of advanced CRC patients.

    at UCLA

  • S0820, Adenoma and Second Primary Prevention Trial

    open to eligible people ages 18 years and up

    The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.

    at UC Irvine UCSD

  • Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer

    open to eligible people ages 18 years and up

    This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, 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. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.

    at UCLA

  • Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation

    open to eligible people ages 18 years and up

    This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

    at UC Davis UC Irvine

  • Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation

    open to eligible people ages 18 years and up

    This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. 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 nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer.

    at UC Irvine

  • Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

    open to eligible people ages 18 years and up

    This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, 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. Giving chemotherapy with radiation therapy may kill more tumor cells. 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 nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.

    at UCSF

  • Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial

    open to eligible people ages 18 years and up

    This trial screens patients with colon or rectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations for recommendation to a molecularly assigned therapy. Identifying gene mutations may help patients enroll onto target companion trials that target these mutations.

    at UCSD

Our lead scientists for Rectal Cancer research studies include .

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