RecruitingPhase 3NCT06752811

Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer

A Multi-center, Randomized, Open, Parallel-group, Positive Drug-controlled Phase III Clinical Trial for Evaluating the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Plus Gemcitabine and Paclitaxel for Injection (Albumin-bound) Plus Gemcitabine for Injection in the First-line Treatment of Metastatic Pancreatic Cancer

Sponsor

Shanghai Yizhong Pharmaceutical Co., Ltd.

Enrollment

416 participants

Start Date

Feb 5, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Metastatic

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new formulation of paclitaxel (a chemotherapy drug) delivered in tiny polymer particles (polymeric micelles) as a first-line treatment for metastatic pancreatic cancer. The goal is to see if it is as effective and safe as standard chemotherapy. **You may be eligible if...** - You are 18–75 years old - You have confirmed metastatic (stage IV) pancreatic cancer - You have not received any prior systemic treatment for metastatic disease (or your last adjuvant treatment ended more than 6 months ago) - You have at least one measurable tumor on CT or MRI - You are in reasonably good health (ECOG 0–2) with expected survival of at least 3 months - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have already received chemotherapy or other systemic treatment for metastatic pancreatic cancer - Your major organ function is significantly impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpaclitaxel 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.

DRUGGemcitabine 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.

DRUGPaclitaxel 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.

DRUGGemcitabine 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.

Locations(2)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06752811

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