198
Participants
Start Date
November 9, 2023
Primary Completion Date
March 31, 2026
Study Completion Date
December 31, 2027
Cetuximab + Envafolimab + mFOLFOXIRI
Cetuximab 500mg/m² + envafolimab 200mg + irinotecan 150 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to max 8 cycles, followed by maintenance with cetuximab 500mg/m² + envafolimab 200mg + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle until PD, unacceptable toxicity or patient's refusal.
Cetuximab + mFOLFOX6/FOLFIRI
Cetuximab 500mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h or cetuximab 500mg/m² + irinotecan 180 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to max 8 cycles, followed by maintenance with cetuximab 500mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle until PD, unacceptable toxicity or patient's refusal.
RECRUITING
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou
RECRUITING
The First People's Hospital of Foshan, Foshan
RECRUITING
Affiliated Cancer Hospital of Guizhou Medical University, Guiyang
Sun Yat-sen University
OTHER