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This study investigates the use of Irinotecan together with Dabrafenib, Trametinib, and an anti-EGFR drug (Cetuximab or Panitumumab) as second-line therapy in people with metastatic colorectal cancer. It enrolls patients with inoperable metastatic colorectal adenocarcinoma that carries a BRAF mutation. It is in Phase 2; it is not currently recruiting but is ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Histologically confirmed metastatic inoperable colorectal adenocarcinoma 2. The tumour has a BRAF mutation 3. Adequate function of hematopoiesis and basic indicators of internal organs 4. Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1). 5. Absence of grade 2 or higher toxicity from previous line of treatment. 6. It is possible to include patients with MSI or dMMR if they have received first-line immune checkpoint therapy. 7. ECOG PS 0-1 Exclusion Criteria: 1. Participants having more than 2 lines of treatment (a progression of disease within 12 months of the completion of adjuvant and/or perioperative chemotherapy with oxaliplatin and fluoropyrimidines is acceptable). 2. Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment. 3. Pregnant and breastfeeding women. 4. Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study. 5. HIV-infected patients. 6. Patients with a life expectancy of less than 3 months. 7. The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.