Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

January 20, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Pancreatic Cancer, Adult
Interventions
DRUG

Nimotuzumab

Patients will receive 3 cycles of neoadjuvant treatment with Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle).

DRUG

AG regimen

Patients will receive 3 cycles of AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle).

DRUG

Placebo

Patients will receive 3 cycles of neoadjuvant treatment with placebo (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant therapy (placebo 400 mg on days 1, 8, and 15 of a 21-day cycle).

Trial Locations (2)

100000

Beijing Cancer Hospital, Beijing

210029

The First Affiliated Hospital with Nanjing Medical University, Nanjing

All Listed Sponsors
collaborator

Peking University Cancer Hospital & Institute

OTHER

collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

lead

Biotech Pharmaceutical Co., Ltd.

OTHER