MedTrace Logo

Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer

NCT06752811 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2026-02-10

No results posted yet for this study

Summary

This trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine.

Conditions

  • Pancreatic Cancer Metastatic

Interventions

DRUG

paclitaxel polymeric micelles for injection

Paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle.

DRUG

Gemcitabine Hydrochloride for Injection

The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks.

DRUG

Paclitaxel for Injection (albumin bound )

Patients in the control group will receive intravenous infusion of paclitaxel for Injection (albumin bound ) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle.

DRUG

Gemcitabine Hydrochloride for Injection

The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks.

Sponsors & Collaborators

  • Shanghai Yizhong Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2027-07-01
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT06752811 on ClinicalTrials.gov