NCT06409429

Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX for postoperative adjuvant treatment of pancreatic cancer.

Detailed description

This clinical study is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX (gemcitabine plus capecitabine) compared with GX only for resected pancreatic cancer. About 146 patients will be enrolled in this study and randomly divided into experimental group (nimotuzumab plus GX) and control group (placebo plus GX) at a ratio of 1:1. The main endpoint is relapse-free survival (RFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Nimotuzumab	Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months.
DRUG	GX	Patients will receive GX as adjuvant therapy for 6 months. Gemcitabine will be delivered as a 1000 mg/m² intravenous infusion administered on Day 1 and 8 of a 21-day cycle. Capecitabine 2000mg/m²/day will be administered orally for 14 days followed by 7 days' rest.
DRUG	Placebo	Patients will receive placebo 400 mg weekly or placebo 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months.

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-05-30
• Completion: 2027-05-30
• First posted: 2024-05-10
• Last updated: 2024-05-10

Locations

1 site across 1 country: China