CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer

Sponsor
Shanghai Changzheng Hospital
Study ID
NCT05585814
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 4 cycles
  • Oxaliplatin — DRUG
    Oxaliplatin is given by intravenous infusion at 130mg / m2 on Day 1 every 3 weeks for 4 cycles
  • Bevacizumab — DRUG
    Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 4 cycles
  • Pembrolizumab — DRUG
    Pembrolizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles

Study Details

This prospective, single-arm study aims to investigate the efficacy and safety of pembrolizumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR/MSS locally advanced rectal cancer patients

Key Dates

First listed
Oct 19, 2022
Start date
May 1, 2023
Status verified
Aug 2026
Primary completion
Sep 18, 2024
Completion
May 9, 2027

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab+ Bevacizumab + CapeOx as neoadjuvant treatment for 4 cycles
    CapeOx: Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 4 cycles and Oxaliplatin is given by intravenous infusion at 130mg / m2 on Day 1 every 3 weeks for 4 cycles; Bevacizumab：Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 4 cycles; Pembrolizumab：Pembrolizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles. Following these 4 cycles, patients receive one additional 21-day bridging cycle of CapeOx (Capecitabine plus Oxaliplatin) before surgery.

Primary Outcome Measure

R0 resection rate [ Time Frame: 15 weeks ]

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