Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

March 30, 2028

Study Completion Date

December 31, 2028

Conditions
Gastric (Stomach) CancerGastric AdenocarcinomaFruquintinibPD-1 InhibitorTislelizumabGEJ Adenocarcinoma
Interventions
DRUG

fruquintinib + tislelizumab + FOLFOX

"phase Ib: fruquintinib (3+3 dose escalation design): L1: 3 mg/d, L2: 4 mg/d, L3: 5 mg/d, qd po, D1-14, Q3W; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin : 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W.~phase II: fruquintinib: RP2D; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin: 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W."

Trial Locations (1)

210000

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER