Phase 3 Study of PD-1 Inhibitor With or Without Local Therapy for Patients with Oligometastatic Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating treatments for patients with oligometastatic esophageal squamous cell carcinoma, a type of cancer with limited distant metastases. The study compares the combination of PD-1 inhibitor with or without chemotherapy plus local therapies against PD-1 inhibitor with or without chemotherapy alone. This phase III randomized study aims to assess progression-free survival as the primary endpoint, with secondary goals including overall survival, side effects, and local tumor control. Participants are randomly assigned in a 21 ratio to one of two groups one receives PD-1 inhibitor with or without chemotherapy combined with local treatments such as radiotherapy, surgery, or radiofrequencymicrowave ablation, while the other group receives only systemic therapy with PD-1 inhibitor with or without chemotherapy. Various local therapy techniques are allowed and planned to target all suspected malignant lesions. During the study, participants will be monitored through regular assessments of cancer progression, survival, treatment side effects, and tumor control at specified time points. Researchers will collect data on acute and late side effects, and local control rates at 1 and 3 years. The study involves follow-up to measure outcomes over three years, providing insights into the benefits and risks of combining local therapies with systemic immunotherapy or chemo-immunotherapy.

Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor