Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a specific type of bile duct or gallbladder cancer called adenocarcinoma, confirmed by a tissue sample (biopsy).
• People whose cancer cannot be surgically removed and has not spread to distant parts of the body, confirmed by a specialist radiologist and surgeon at the treating hospital.
• People aged 18 years or older.
• People who have not previously received any systemic (whole-body) treatment for their cancer.
• People who are in good enough general health to carry out daily activities with little or no limitation (confirmed with trial site for exact fitness level required).
• People with a life expectancy of more than 3 months.
• People who have at least one tumour that can be measured on a scan.
• People whose blood counts, liver function, kidney function, and blood clotting results fall within the ranges required by the trial, based on tests taken within 14 days before starting treatment.
• People with liver cirrhosis, provided their liver function meets a specific scoring level (Child-Pugh class A or B7).
• People with a history of hepatitis B, provided they have been on antiviral treatment for at least 4 weeks and the virus is undetectable before joining.
• People with a history of hepatitis C, provided they have completed curative antiviral treatment at least 4 weeks before joining and the virus is undetectable.
• People who are HIV positive, provided the virus is undetectable and their immune cell count meets the required level at screening.
• People who are able to use effective contraception as required by the trial, or who are post-menopausal or surgically sterile (for women).
• People who are willing and able to sign an informed consent form, including agreement that the costs of certain chemotherapy drugs will be charged to them or their insurer.
• People who are able to follow the study procedures as judged by the investigating team.

Who may not be able to join:

• People whose cancer is a type other than adenocarcinoma, such as mixed liver-bile duct cancer, adenosquamous carcinoma, mixed adenocarcinoma/neuroendocrine carcinoma, or ampullary carcinoma.
• People whose cancer is considered surgically removable, or whose cancer has spread to distant parts of the body including distant lymph nodes.
• People who have previously received systemic chemotherapy, an investigational therapy, or certain immune-based treatments (such as checkpoint inhibitor drugs) for their cancer.
• People currently receiving any other investigational treatment or cancer-fighting therapy (hormone therapy is generally acceptable — confirm with trial site).
• People who have previously had radiotherapy to the bile duct or gallbladder area.
• People who have previously had surgical removal of their bile duct or gallbladder cancer.
• People who have had major surgery or a serious injury within 14 days before starting the trial, or who are still recovering from side effects of a recent procedure.
• People with an active autoimmune disease or immune deficiency condition (such as lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions), with some limited exceptions for mild, well-controlled skin conditions.
• People with a history of certain serious lung conditions, such as pulmonary fibrosis, interstitial lung disease, or drug-induced lung inflammation, or who show signs of active lung inflammation on a screening scan.
• People with a known allergy or sensitivity to any of the study drugs or similar compounds.
• People with a history of severe allergic reactions to certain types of antibody-based medicines.
• People with significant nerve damage in their hands or feet (peripheral neuropathy above a moderate level).
• People with a diagnosed immune deficiency, or who have been taking immune-suppressing medications or high-dose steroids within 7 days before starting the trial.
• People who have been taking immune-suppressing medications within two weeks before starting the trial, or who are expected to need such medications during the study (with one limited exception — confirm with trial site).
• People who have another cancer that is currently active or has required treatment within the past 3 years, with some exceptions for certain minor skin cancers or carcinoma in situ that have been treated.
• People with an active infection currently requiring treatment with medicines taken throughout the body.
• People with active tuberculosis.
• People with both active hepatitis B and active hepatitis C infections at the same time.
• People who have received certain blood cell-stimulating injections within 28 days before starting the trial.
• People with significant heart or blood vessel problems, such as a heart attack or stroke within the past 12 months, uncontrolled high blood pressure, or unstable heart rhythm or chest pain within the past 3 months.
• People whose heart electrical measurement (QTc interval) on an ECG is above the level specified by the trial.
• People who have had a stem cell transplant or solid organ transplant at any time.
• People who have received a live vaccine within 4 weeks before starting the trial, or who expect to need one during treatment.
• People with a condition, treatment history, or test result that could affect the trial results or make full participation unsafe, in the opinion of the treating doctor.
• People with known psychiatric illness or substance use problems that would make it difficult to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the study period or within 120 days after the last dose of trial treatment.
• People who, in the investigator's judgement, are unlikely to be able to follow all study procedures and requirements.

Important: Always verify eligibility with the trial site directly before applying.