A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer

Sponsor
Chinese PLA General Hospital
Study ID
NCT07527026
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    patients first receive 2 cycles of camrelizumab combined with CAPOX (capecitabine 1000 mg/m² orally twice daily on days 1-14; oxaliplatin 130 mg/m² intravenously every 3 weeks). This is followed by long-course chemoradiotherapy (LCRT): a total dose of 50.4 Gy delivered in 28 fractions, with concurrent capecitabine 825 mg/m² orally twice daily.

Study Details

In pMMR/MSS locally advanced rectal cancer, can the innovative "chemo-immunotherapy induction + LCRT + chemo-immunotherapy consolidation" approach significantly improve the complete response rate and create opportunities for organ preservation?

Key Dates

Start date
Feb 1, 2026
Status verified
Apr 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2029

Study Design

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

Arms

  • Experimental: experimental group
    Camrelizumab combined LCRT

Primary Outcome Measure

CR rate [ Time Frame: cCR is assessed at 4-6 weeks post-therapy by imaging/endoscopy; pCR is assessed postoperatively (surgery at 4-6 weeks post-therapy + pathology within 1-2 weeks after surgery). ]

Central Contacts

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