Phase II Study of Penpulimab Plus Chemotherapy With or Without Anlotinib as First Treatment in Adults With Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the combination of Penpulimab plus chemotherapy, with or without Anlotinib, as a first-line treatment for patients with advanced esophageal squamous cell carcinoma who are not candidates for curative therapy. This phase II, open-label study aims to compare these two treatment approaches to better understand their effects on tumor response and patient outcomes. Participants will be randomly assigned to one of two groups. Group A will receive Penpulimab plus chemotherapy alongside Anlotinib every three weeks for 4 to 6 cycles during the initial treatment phase, followed by maintenance therapy with Anlotinib and Penpulimab every three weeks until disease progression or intolerance. Group B will receive Penpulimab plus chemotherapy every three weeks for 4 to 6 cycles initially, then Penpulimab maintenance every three weeks until disease progression, after which both Anlotinib and Penpulimab may be used until further progression or intolerance. Throughout the study, participants will undergo regular assessments including tumor measurements to evaluate the objective response rate over about two years. Other outcomes such as disease control, progression-free survival, overall survival, and quality of life changes will be monitored. Safety evaluations will include adverse event tracking. The study expects to follow patients up to three years, with ongoing monitoring to understand treatment effects and patient well-being during and after therapy.

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