SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor for the Treatment of RAS-Mutant, MSS-Type, Unresectable Metastatic Colorectal Cancer.

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Feb 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a combination treatment for patients with a specific type of advanced colorectal cancer called RAS-mutant, microsatellite stable (MSS), unresectable metastatic colorectal cancer. The treatment involves a method known as stereotactic body radiation therapy (SBRT) combined with a chemotherapy regimen (CAPEOX), a medication that helps stop the growth of blood vessels in tumors (bevacizumab), and a type of immunotherapy that boosts the body’s immune response (a PD-1 inhibitor). The goal is to see if this combination can effectively treat this difficult-to-manage cancer.

To be eligible for the trial, participants should be between 18 and 75 years old and must have a confirmed diagnosis of colorectal cancer that cannot be surgically removed. They should have specific genetic characteristics (RAS mutation-positive) and be in relatively good health, meaning they should have no major health issues that would prevent them from participating. Participants can expect regular monitoring during the trial and will need to sign a consent form agreeing to follow the study's guidelines. It’s important to note that this trial is not yet recruiting participants, so there will be no immediate involvement.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18-75 years, regardless of gender.
• • Lower edge of the lesion located ≥12 cm from the anal verge.
• • Histologically confirmed colorectal adenocarcinoma.
• • Confirmed as unresectable by multidisciplinary team (MDT) evaluation.
• • RAS mutation-positive.
• • Microsatellite/mismatch repair status: MSS/pMMR.
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • Expected survival ≥3 months.
• * Adequate hematological, hepatic, and renal function:
• • Neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥75 × 10⁹/L; Serum total bilirubin ≤1.5 × upper normal limit (UNL); Aspartate aminotransferase (AST) ≤2.5 × UNL; Alanine aminotransferase (ALT) ≤2.5 × UNL; Serum creatinine ≤1.5 × UNL.
• • Karnofsky Performance Status (KPS) score ≥70.
• • Adequate organ function with no contraindications to surgery, radiotherapy, chemotherapy, or immunotherapy.
• • No prior chemotherapy or other antitumor therapy before enrollment.
• • No prior immunotherapy received.
• • Willingness and ability to comply with the study protocol during the trial period.
• • Signed written informed consent.
• Exclusion Criteria:
• • Patients who have received antibodies against programmed death receptor-1 (PD-1) or its ligand (PD-L1), as well as antibodies against cytotoxic T lymphocyte associated antigen 4 (CTLA-4).
• • Patients with any active autoimmune diseases or a history of requiring steroid or immunotherapy treatment.
• • Complex situations with concurrent active bleeding, perforation, or requiring emergency surgery.
• • Have received systemic anti-cancer treatment for rectal cancer.
• • Simultaneously present with other non colorectal cancer tumor diseases.
• • Patients with interstitial lung disease, non infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia).
• • Any grade 2 or above toxic reactions (classified according to the Common Terminology Criteria for Adverse Events (CTCAE) 5th edition) caused by previous treatment that have not subsided (excluding anemia, hair loss, and skin pigmentation).
• • Pregnant or lactating women.
• • Patients who are known or have been tested for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
• • Known or suspected history of allergies to any relevant drugs used in the trial