PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer

The treatment efficacy for stage IVb esophageal cancer has been improved through chemotherapy combined with immunotherapy recently. On this basis, the investigators intend to conduct a prospective, multicenter phase III clinical trial to assess whether radiotherapy with concurrent chemotherapy and immunotherapy could further improve the survival of patients with metastatic esophageal cancer. Accompanied tissue samples, blood samples and urine samples will be analyzed by molecular biological detection (Including Whole Exome Sequencing and proteomics) to explore potential biomarkers for predicting outcomes, efficacy and toxicity.

NCT Number	NCT06086457
Lead Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences Collaborators: Peking University Cancer Hospital & Institute, Beijing Cancer Prevention & Treatment Society, Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital, Fujian Cancer Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Sichuan Cancer Hospital and Research Institute, Tengzhou Central People's Hospital, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Affiliated Hospital of North Sichuan Medical College, Changzhou Cancer Hospital of Soochow University, Henan Cancer Hospital
Conditions	Esophageal Neoplasms
Enrollment	436 participants
Start Date	2024-02-04
Primary Completion	2026-06-28 (estimated)
Study Completion	2029-08-28 (estimated)
Updated on ClinicalTrials.gov	2024-07-16