ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06543836
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab — DRUG
    Sintilimab 200mg, d1, with a treatment cycle of 21 days, and efficacy assessment every 2 cycles.
  • Fruquintinib or Regorafenib — DRUG
    The treatment regimen consists of the following options: Option 1: Fruquintinib 5mg Qd, d1-21, Q4w, and efficacy assessment every 1.5 months. Option 2: Regorafenib 160mg Qd, d1-21, Q4w, and efficacy assessment every 1.5 months.
  • Fruquintinib — DRUG
    Fruquintinib 5mg Qd, d1-14, with a treatment cycle of 21 days, and efficacy assessment every 2 cycles.

Study Details

The efficacy of combining TKI with PD-1 inhibitor in the treatment of advanced MSS/pMMR colorectal cancer with low levels of maxVAF in peripheral blood ctDNA failed with standard treatment was assessed, compared to standard treatment as chosen by researchers.

Key Dates

First listed
Aug 9, 2024
Start date
Dec 1, 2023
Status verified
Aug 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

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

Arms

  • Experimental: PD-1 inhibitor+Tyrosine kinase inhibitor(TKI)
    PD-1 inhibitor: Sintilimab 200mg, d1, TKI: Fruquintinib 5mg Qd, d1-14, Q3w. Efficacy assessment every 2 cycles.
  • Active Comparator: Tyrosine kinase inhibitor(TKI)
    The treatment regimen consists of the following options: Option 1: Fruquintinib 5mg Qd, d1-21, Q4w, and efficacy assessment every 1.5 months. Option 2: Regorafenib 160mg Qd, d1-21, Q4w, and efficacy assessment every 1.5 months.

Primary Outcome Measure

PFS [ Time Frame: Up to 2 years ]

Central Contacts

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