Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)

Sponsor
Fudan University
Study ID
NCT07150949
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Rectal Cancer
  • Neoadjuvant Therapy

Eligibility Criteria

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

Interventions

  • Long-course radiotherapy — RADIATION
    Long-course radiation: 50Gy/25Fx
  • Oxaliplatin — DRUG
    Oxaliplatin: 130mg/m2 d1 q3w
  • Capecitabine — DRUG
    Xeloda
  • Celecoxib — DRUG
    celecoxib 200 mg orally twice a day
  • Short-course radiotherapy — RADIATION
    Short-course radiotherapy: 25Gy/5Fx
  • Serplulimab — DRUG
    Serplulimab 300mg, d1, q3w

Study Details

SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4/N+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy/25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. The COX2 inhibitor celecoxib 200 mg was started orally twice a day during chemotherapy until the end of neoadjuvant treatment.TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Key Dates

Start date
Aug 28, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Long-course Radiotherapy plus chemotherapy group
  • Experimental: Short-course Radiotherapy plus immunochemotherapy group

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: 1 month after the surgery or the decision of W&W ]

Central Contacts

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