Clinical trial · Interventional
SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor for the Treatment of RAS-Mutant, MSS-Type, Unresectable Metastatic Colorectal Cancer.
Evaluation of the Efficacy and Safety of SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor in RAS-Mutant, MSS-Type, and Unresectable Metastatic Colorectal Cancer: a Single-center, Single-arm, Open-label Clinical Trail.
NCT06835179CI-TRIAL-00086194not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Microsatellite Stable (MSS) Colorectal Cancer (CRC) | Colorectal Carcinoma | ALIAS | 0.85 |
| RAS-mutant Colorectal Cancer | — | UNRESOLVED | — |
| Unresectable Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CapeOX + bevacizumab | Drug | — | UNRESOLVED |
| PD-1 Inhibitors | Drug | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Patients first receive short-course SBRT (total dose of 30-60 Gy, completed in 3-5 fractions). Within two weeks after SBRT, the liver function and other toxicity reactions of patients are closely monitored to ensure they can tolerate subsequent drug treatment. Then, patients proceed to drug therapy: each treatment cycle lasts for 21 days, including intravenous administration of tislelizumab (200mg on day 1), bevacizumab (7.5mg/kg on day 1), oxaliplatin (135mg/m² on day 1), as well as oral capecitabine (1g/m² twice daily from day 1 to day 14). Up to six cycles of induction therapy may be administered
- interventionNames
- Radiation: SBRT
- Drug: PD-1 Inhibitors
- Drug: CapeOX + bevacizumab
Primary outcomes (1)
- measure
- Objective response rate (ORR rate)
- timeFrame
- 1 year
- description
- ORR is defined as the proportion of patients who achieve the best objective response, either complete response (CR) or partial response (PR), according to the RECIST criteria (version 1.1).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.