Neoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal Cancer

Sponsor
Changhai Hospital
Study ID
NCT07134218
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • serplulimab、bevacizumab — DRUG
    short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 2 cycles of FOLFOX + serplulimab + bevacizumab → 2 cycles of FOLFOX + serplulimab.
  • neoadjuvant chemoradiation therapy — OTHER
    short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 4 cycles of FOLFOX alone.

Study Details

This is a multicenter, prospective, randomized phase II trial designed to evaluate the efficacy and safety of short-course neoadjuvant chemoradiotherapy combined with the PD-1 monoclonal antibody serplulimab and the anti-angiogenic agent bevacizumab in patients with previously untreated pMMR/MSS middle and low locally advanced rectal cancer. The study plans to enroll a total of 200 participants (100 in the experimental arm and 100 in the control arm).

Key Dates

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

Study Design

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

Arms

  • Experimental: neoadjuvant chemoradiation therapy + serplulimab + bevacizumab
  • Other: neoadjuvant chemoradiation therapy

Primary Outcome Measure

The rate of cCR [ Time Frame: 2 years ]

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