Neoadjuvant Safety of Sintilimab + XELOX + Bevacizumab in PMMR/MSS CRLM Patients

Sponsor
Sun Yat-sen University
Study ID
NCT04940546
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Sintilimab — DRUG
    Mode of administration: Intravenously
  • Oxaliplatin — DRUG
    Mode of administration: Intravenously
  • Capecitabine — DRUG
    Mode of administration: Orally
  • Bevacizumab — DRUG
    Mode of administration: Intravenously

Study Details

This prospective, single arm study aims to evaluate the preoperative neoadjuvant safety of Sintilimab combined with XELOX plus bevacizumab in colorectal patients with liver metastasis and pMMR/MSS status.

Key Dates

First listed
Jun 25, 2021
Start date
Jun 16, 2021
Status verified
Nov 2024
Primary completion
Oct 30, 2023
Completion
Oct 30, 2025

Study Design

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

Arms

  • Experimental: Sintilimab + XELOX + Bevacizumab
    Patients receive Sintilimab + XELOX regimen every 3 weeks for 4 cycles and Bevacizumab every 3 weeks for 2 cycles. Details are as follows: Sintilimab: 200mg intravenously, d1 Oxaliplatin: 135mg/m2 intravenously, d1 Capecitabine: 2g/m2 orally, d1-14 for Bevacizumab: 7.5mg/kg intravenously, d1 After neoadjuvant treatment, if there are no new lesions upon radiological and Multidisciplinary Team (MDT) assessment, radical surgery is performed within 6 weeks. If there are new lesions the surgical team will assess the optimal time for surgery. After surgery 4 cycles of XELOX regimen is advised for adjuvant therapy.

Primary Outcome Measure

Adverse events [ Time Frame: up to 24 months ]

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