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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

NCT06706895 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-11-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06706895 on ClinicalTrials.gov