Fruquintinib Combined With PD-1 Inhibitor as First-line Maintenance Therapy for Advanced Gastric Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

December 31, 2028

Conditions
Gastric AdenocarcinomaGEJ AdenocarcinomaFirst-line TherapyMaintenance TherapyFruquintinibPD-1
Interventions
DRUG

Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX)

"CAPOX/SOX (each cycle is 21 days): Oxaliplatin 130mg/m2, ivgtt, D1; Capecitabine 1000 mg/m2, po, bid, D1-14 or S-1: 40-60mg according to BSA, bid, D1-14.~FOLFOX (each cycle is 14 days): Oxaliplatin 85mg/m2, ivgtt, D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours; Leucovorin: 400mg/m2, iv, D1.~PD-1 monoclonal antibody:~Nivolumab 360mg/3 weeks or 240mg /2 weeks, iv, D1; If weight ≥60 kg, Sintilimab 200mg/3 weeks; if weight \< 60 kg, Sintilimab 3mg/kg/3 weeks, iv, D1; Tislelizumab 200mg/3 weeks, iv, D1; Pembrolizumab 200mg/3 weeks, iv, D1;"

DRUG

Maintenance treatment (after 3 months): fruquintinib+PD-1

"After 3 months (12 weeks) of initial treatment with oxaliplatin-based chemotherapy combined with PD-1 monoclonal antibody, those with complete response (CR), partial response (PR) or stable disease (SD) assessed by imaging evaluation continued to receive maintenance treatment with furoquininib and PD-1 monoclonal antibody.~Fruquintinib 3 mg/d, qd po, D1-21, Q4W; PD-1 monoclonal antibody is repeated as initial treatment until the disease progresses or unacceptable toxicity."

Trial Locations (1)

210000

Ruijin Hospital, Shanghai

All Listed Sponsors
lead

Ruijin Hospital

OTHER