NCT06706895

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open, phase II clinical trial aimed at evaluating the anti-tumor efficacy and safety of paclitaxel polymeric micelles for injection combined with furquintinib as second-line treatment for advanced gastric cancer.

Conditions

• Advanced Gastric Cancer
• Paclitaxel Polymeric Micelles for Injection
• Fruquintinib Capsules

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-11-27
• Last updated: 2024-11-27