Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab in the Treatment of Refractory mCRC.

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06060704
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Envafolimab — DRUG
    150mg Qw, delivered as a single 1.5ml subcutaneous injection in under 30s , every 4 weeks for one cycle(Q4w).
  • Trifluridine/Tipiracil — DRUG
    35 mg/m2 (maximum single dose of 80 mg), po, on days 1-5 and 8-12 of each treatment cycle, twice daily for 28 days, within 1 hour after breakfast or dinner take medicine.
  • Bevacizumab — DRUG
    ivgtt, 5mg/kg, d1, d15, every 4 weeks for one cycle (Q4w). The subjects will receive Trifluridine/Tipiracil plus Bevacizumab and Envafolimab until disease progression, intolerable toxicity, initiation of other anti-tumor therapy, death, withdrawal of informed consent, or loss of follow-up.

Study Details

The goal of this single-arm study is to evaluate the efficacy and safety of Envafolimab combined with Trifluridine/Tipiracil and Bevacizumab in the treatment of metastatic colorectal cancer patients who are refractory or intolerant to standard therapy.

Key Dates

First listed
Sep 29, 2023
Start date
Nov 30, 2023
Status verified
Oct 2023
Primary completion
Mar 31, 2025
Completion
Sep 30, 2025

Study Design

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

Arms

  • Experimental: triplet combination therapy
    Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab

Primary Outcome Measure

ORR（Objective response rate） [ Time Frame: Approximately 12 months ]

Central Contacts

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