Short Course Radiotherapy Followed by CAPOX and Carrilizumab and Bevacizumab or Cetuximab for the Initial Treatment of Unresectable Metastatic Rectal Cancer

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07059949
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • CAPOX
  • Combination of Radioimmunotherapy
  • Unresectable Metastatic Rectal Cancer

Eligibility Criteria

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

Interventions

  • CAPOX+ Camrelizumab+ Cetuximab — DRUG
    For advanced primary treatment of unresectable rectal cancer, primary radiation therapy DT 25Gy/5F, and rest for 1 week, followed by CAPOX chemotherapy + Camrelizumab + Bevacizumab or Cetuximab (KRAS, NRAS, and BRAF all wild-type Cetuximab, KRAS, NRAS, and BRAF variants selected Bevacizumab) for 4-6 months, after which Capecitabine + Camrelizumab + Bevacizumab or Cetuximab was maintained
  • CAPOX+ Camrelizumab+ Bevacizumab — DRUG
    For advanced primary treatment of unresectable rectal cancer, primary radiation therapy DT 25Gy/5F, and rest for 1 week, followed by CAPOX chemotherapy + Camrelizumab + Bevacizumab or Cetuximab (KRAS, NRAS, and BRAF all wild-type Cetuximab, KRAS, NRAS, and BRAF variants selected Bevacizumab) for 4-6 months, after which Capecitabine + Camrelizumab + Bevacizumab or Cetuximab was maintained

Study Details

To evaluate the efficacy and safety of short-course radiotherapy followed by CAPOX and carrilizumab and bevacizumab or cetuximab in the initial treatment of unresectable metastatic rectal cancer

Key Dates

Start date
Jun 30, 2025
Status verified
Apr 2025
Primary completion
Jan 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Can't remove RAS/BRAF completely wild
    CAPOX+ Camrelizumab + Cetuximab
  • Experimental: RAS/BRAF mutations cannot be resected
    CAPOX+ Camrelizumab + Bevacizumab

Primary Outcome Measure

ORR [ Time Frame: From enrollment to initial efficacy evaluation,assessed up to 6 months ]