CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer

Sponsor
Shanghai Changzheng Hospital
Study ID
NCT06881537
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Recurrent Colorectal 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
  • Tislelizumab — DRUG
    Tislelizumab 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 CapeOX combined with Bevacizumab plus Anti-PD1 Antibody as neoadjuvant therapy for locally recurrent colorectal cancer

Key Dates

First listed
Mar 18, 2025
Start date
Jun 1, 2024
Status verified
Mar 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment
    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; Tislelizumab：Tislelizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles

Primary Outcome Measure

Objective response rate [ Time Frame: 15 weeks ]

Central Contacts