NCT05214222

Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma

Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study.

Detailed description

This is a open-label, phase II study of Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy in subjects With resectable advanced esophageal squamous cell carcinoma. The patients will be divided into two groups. In group A, Penpulimab plus chemotherapy with Anlotinib will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Anlotinib and Penpulimab will be used every 3 weeks until disease progression or intolerance; In group B, Penpulimab plus chemotherapy will be given every 3 weeks for 4-6 cycles in initial stage, then penpulimab will be used every 3 weeks until disease progression, Anlotinib and Penpulimab will be used every 3 weeks until disease progression again or intolerance;

Conditions

• Advanced Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Anlotinib/Penpulimab/Chemotherapy	Initial treatment (4-6 cycles): Anlotinib, Penpulimab, Paclitaxel or Albumin Paclitaxel,Cisplatin * Anlotinib: once a day, 1 capsule each time (10mg for body weight \<60KG, 12mg for body weight ≥60KG), d1-d14, 3 weeks as a treatment cycle. * Penpulimab: 200 mg, d1 per cycle, once every 3 weeks. * Paclitaxel: According to 135-175mg/m2, intravenous infusion\> 2h, d1, 3 weeks as a treatment cycle; Albumin paclitaxel: According to 200-260mg/m2, intravenous infusion for 30 minutes, d1, 3 weeks as a treatment cycle. * Cisplatin: 60-75mg/m2, intravenous infusion, divided into d1-d3 medication per cycle; 3 weeks is a treatment cycle. Maintenance treatment: Anlotinib, Penpulimab * Anlotinib: once a day, 1 capsule each time (the same as the initial treatment dose), take the drug every cycle d1-d14, 3 weeks as a treatment cycle. * Penpulimab: 200mg, d1 per cycle, once every 3 weeks
DRUG	Penpulimab/Chemotherapy	Initial treatment (4-6 cycles): Penpulimab, Paclitaxel or Albumin Paclitaxel,Cisplatin * Penpulimab: 200 mg, d1 per cycle, once every 3 weeks. * Paclitaxel: According to 135-175mg/m2, intravenous infusion\> 2h, d1, 3 weeks as a treatment cycle; Albumin paclitaxel: According to 200-260mg/m2, intravenous infusion for 30 minutes, d1, 3 weeks as a treatment cycle. * Cisplatin: 60-75mg/m2, intravenous infusion, divided into d1-d3 medication per cycle; 3 weeks is a treatment cycle. Maintenance treatment: Penpulimab • Penpulimab: 200mg, d1 per cycle, once every 3 weeks Post-progression genetic testing, continued treatment: Anlotinib,Penpulimab Anlotinib: Once daily, one capsule per time (10mg for weight \<60KG, 12mg for weight ≥60KG), administered from day 1 to day 14 of each cycle. Two consecutive weeks of treatment followed by one week off, 3 weeks per treatment cycle. Penpulimab: 200mg, administered on day 1 of each cycle, every 3 weeks.

Timeline

• Start date: 2022-09-02
• Primary completion: 2026-06-02
• Completion: 2028-09-02
• First posted: 2022-01-28
• Last updated: 2024-12-30

Locations

1 site across 1 country: China