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 range
18 Years – 75 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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