SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT07549399
Phase
PHASE3
Status
Recruiting
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Conditions

  • High-Risk Cancer
  • MSS
  • Rectal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Short-Course Radiotherapy — RADIATION
    Patients undergo SCRT at a dose of 5Gy × 5 fractions
  • PD-1 monoclonal antibody — DRUG
    Patients complete immune therapy with PD-1 monoclonal antibody for 4 cycles.
  • mFOLFOX6 regimen — DRUG
    Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles.
  • Cetuximab — DRUG
    Patients with RAS/BRAF wild-type receive targeting therapy with Cetuximab for 4 cycles.
  • Bevacizumab — DRUG
    Patients with RAS/BRAF mutations receive targeting therapy with Bevacizumab for 3 cycles. (Bevacizumab is not used in the last cycle of the bevacizumab group)
  • Surgical resection — PROCEDURE
    Surgery either local excition or total mesorectal excision is performed 8-10 weeks after the completion of short-course radiotherapy.

Study Details

To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.

Key Dates

First listed
Apr 24, 2026
Start date
May 20, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

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

Arms

  • Experimental: SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy
    The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody, and molecularly targeted drugs (selected based on RAS status; patients with RAS/BRAF wild-type receive cetuximab, while those with RAS/BRAF mutations receive bevacizumab). After completing the first cycle of mFOLFOX6 chemotherapy combined with targeted and immune therapy, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy combined with PD-1 monoclonal antibody and targeted drugs (bevacizumab is not used in the last cycle of the bevacizumab group). Surgery is performed 8-10 weeks after the completion of SCRT.
  • Active Comparator: SCRT + mFOLFOX6
    The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen. After completing the first cycle of mFOLFOX6 chemotherapy, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy. Surgery is performed 8-10 weeks after the completion of SCRT.

Primary Outcome Measure

3 years DFS Rate [ Time Frame: 3 years ]

Central Contacts

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