A Single-arm, Single-center Phase II Clinical Study on the Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Combined With Fruquintinib Capsules in the Second-line Treatment of Patients With Advanced Gastric Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Advanced Gastric CancerPaclitaxel Polymeric Micelles for InjectionFruquintinib Capsules
Interventions
DRUG

Paclitaxel Polymeric Micelles for Injection combined with Fruquintinib Capsules

"Fruquintinib Capsules:4 mg / day, orally once daily on days 1-14 in 21-day cycles. If the patient has AE of grade 3 or above, the dose of fruquintinib capsules is reduced to 3 mg / day(dose discontinuation to dose reduction).~Paclitaxel Polymeric Micelles for Injection:150mg / m2 intravenously over 3 hours on Days1,8 of each 21-day cycle. Do not need special infusion device.~Paclitaxel Polymeric Micelles for Injection and Fruquintinib Capsules are used for 6 cycles. Subsequently, dual-drug or single-drug maintenance therapy was selected according to the tolerance of the patients. Subsequently, Paclitaxel Polymeric Micelles for Injection ( 120mg / m2, if the patient is intolerable, the dose can be reduced to 100mg / m2 ), until occur the disease progress, the intolerant toxicity or the patient withdrawal."

All Listed Sponsors
lead

Shanghai Zhongshan Hospital

OTHER