Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

416

Participants

Timeline

Start Date

February 5, 2025

Primary Completion Date

July 1, 2027

Study Completion Date

December 31, 2027

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.

Trial Locations (2)

201400

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

210029

NOT_YET_RECRUITING

Jiangsu Province Hospital, Nanjing

All Listed Sponsors
lead

Shanghai Yizhong Pharmaceutical Co., Ltd.

INDUSTRY