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

NCT06835179 | Not Yet Recruiting Phase 2

• 1 other identifier: PRSYM202502
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Unresectable Metastatic Colorectal Cancer; Microsatellite Stable (MSS) Colorectal Cancer (CRC); RAS-mutant Colorectal Cancer

Keywords

SBRT; CAPEOX; Bevacizumab; PD-1 Inhibitor; RAS-Mutant; Microsatellite Stable (MSS); Unresectable Metastatic Colorectal Cancer (mCRC)

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR rate)

  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).

  1 year

Secondary Outcomes (2)

• Disease Control Rate (DCR)

  1 year

• Progression Free Survival (PFS)

  2 years

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Radiation: SBRT; Drug: PD-1 Inhibitors; Drug: CapeOX + bevacizumab

Interventions

SBRT RADIATION

SBRT short course radiotherapy (total dose 30-60 Gy, completed in 3-5 sessions)

Experimental group

PD-1 Inhibitors DRUG

Tislelizumab (200mg on day 1)

Experimental group

CapeOX + bevacizumab DRUG

intravenous administration of 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)

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Spinocerebellar Degenerations; Colorectal Neoplasms

Interventions

Immune Checkpoint Inhibitors; Bevacizumab

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yueming Sun

CONTACT

025-68306026; sunyueming@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 19, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share