NCT06586242

Efficacy and Safety of Penpulimab Combined With Anlotinib and Chemotherapy

A Two Arm, Randomized, Prospective, Multicenter Study of Penpulimab Combined With Anlotinib Hydrochloride and Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Esophageal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a two arm, randomized, prospective, multicenter study on the perioperative treatment of locally advanced resectable esophageal cancer with penpulimab combined with anlotinib hydrochloride and chemotherapy.

Detailed description

The study was a two arm, randomized, prospective, multicenter study. The experimental group was treated with penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin, and the control group was treated with penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin	200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, Penpulimab:administered on the first day of each cycle Anlotinib:Body weight \<60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w

Timeline

• Start date: 2023-04-03
• Primary completion: 2025-04-01
• Completion: 2036-04-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China