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

PHASE2RecruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

November 30, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

September 30, 2025

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Envafolimab

150mg Qw, delivered as a single 1.5ml subcutaneous injection in under 30s , every 4 weeks for one cycle(Q4w).

DRUG

Trifluridine/Tipiracil

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.

DRUG

Bevacizumab

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.

Trial Locations (1)

210029

RECRUITING

The First Affiliated Hospital with Nanjing Medical University, Nanjing

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER