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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06835179
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SBRT — RADIATION
    SBRT short course radiotherapy (total dose 30-60 Gy, completed in 3-5 sessions)
  • PD-1 Inhibitors — DRUG
    Tislelizumab (200mg on day 1)
  • 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)

Study Details

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

Key Dates

First listed
Feb 19, 2025
Start date
Feb 28, 2025
Status verified
Feb 2025
Primary completion
Feb 28, 2027
Completion
May 31, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    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

Primary Outcome Measure

Objective response rate (ORR rate) [ Time Frame: 1 year ]

Central Contacts

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