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

• Status: Recruiting
• Trial end date: 2029-08-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Affiliated Hospital of North Sichuan Medical College; Anyang Tumor Hospital; Beijing Cancer Prevention & Treatment Society; Changzhou Cancer Hospital of Soochow University; First Affiliated Hospital Xi'an Jiaotong University; Fujian Cancer Hospital; Hebei Medical University Fourth Hospital; Henan Cancer Hospital; Peking University Cancer Hospital & Institute; Second Affiliated Hospital of Xi'an Jiaotong 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; The First Affiliated Hospital with Nanjing Medical University; Tianjin Medical University Cancer Institute and Hospital
• Treatments: Immune Checkpoint Inhibitors

Criteria

Inclusion Criteria:

• 1. ≥18 years, any gender

• 2. Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer. The initial clinical stage is IVb (2018 American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 8th Edition) , with distant metastasis involving no more than 2 organs (lymph node metastasis is counted);

• 3. ECOG (Eastern Cooperative Oncology Groupper) formance status <= 1. Patients aged 65 years and over need to complete G8 screening or Comprehensive Geriatric Assessment, and the final evaluation is good;

• 4.There was no significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function;

• 5.No prior history of thoracic radiation;

• 6.Expected survival is more than 12 weeks;

• 7.Informed consent provided.

Exclusion Criteria:

• 1.Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.

• 2.Received surgery (except ostomy), chemotherapy or other anti-tumor treatment before enrollment；

• 3. Active infection currently exists . The following conditions occurred within 6 months before randomization: myocardial infarction, cerebrovascular accident, or received gastrointestinal, neurological, cardiopulmonary surgery;

• 4. History of allergy to chemotherapy drugs or autoimmune disease;

• 5. Participate in other clinical trials at present or within 4 weeks before enrollment;

• 6.There are factors such as high risk of fistula that radiotherapy cannot be safely carried out as assessed by the radiation oncologist.