SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor for the Treatment of RAS-Mutant, MSS-T… (NCT06835179) | Clinical Trial Compass
Not Yet RecruitingPhase 2
SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor for the Treatment of RAS-Mutant, MSS-Type, Unresectable Metastatic Colorectal Cancer.
28 participantsStarted 2025-02
Plain-language summary
SBRT Combined with CAPEOX, Bevacizumab, and PD-1 Inhibitor in RAS-Mutant, Microsatellite Stable (MSS), Unresectable Metastatic Colorectal Cancer (mCRC): a Single-center, Single-arm, Open-label Clinical Trail
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 requi…
What they're measuring
1
Objective response rate (ORR rate)
Timeframe: 1 year
Trial details
NCT IDNCT06835179
SponsorThe First Affiliated Hospital with Nanjing Medical University