Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT06764680
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chemotherapy
  • Colorectal Cancer Metastatic
  • Immunotherapy
  • Radiotherapy, Intensity-Modulated
  • Targeted Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trifluorouracil tepidopyrimidine — DRUG
    30mg/m2. P.O. bid. d1-d5 and d15-d19. q4w
  • Bevacizumab — DRUG
    5mg/kg. ivgtt. d1 and d15. q4w
  • Sindilizumab — DRUG
    200mg. ivgtt. d1. q4w
  • IMRT — RADIATION
    In terms of obstruction, bleeding, compression, or pain due to a tumor that requires local treatment. IMRT was delivered to the involved lesions.

Study Details

The current phase 2, double cohort clinical trial was designed to determine the effectiveness of Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab with/without involved lesions irradiation as 3rd- or later-line therapy for advanced MSS/pMMR colorectal cancer.

Key Dates

First listed
Jan 8, 2025
Start date
Dec 31, 2024
Status verified
Nov 2024
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
57 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: three-drug combination
    trifluorouracil tepidopyrimidine, bevacizumab, and sindilizumab
  • Experimental: three-drug combination and radiotherapy
    trifluorouracil tepidopyrimidine, bevacizumab, and sindilizumab combine with palliative radiotherapy of the lesions

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Baseline, 6-8 weeks after treatment complete ]

Central Contacts

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