About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Radiation
- TP or PF regimen depended on investigator's choice.
- PD-1 inhibitor
Treatment groups
Sponsors and collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
Beijing Cancer Prevention & Treatment Society
Collaborator
Hebei Medical University Fourth Hospital
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Fujian Cancer Hospital
Collaborator
Anyang Tumor Hospital
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Tengzhou Central People's Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator
Affiliated Hospital of North Sichuan Medical College
Collaborator
Changzhou Cancer Hospital of Soochow University
Collaborator
Henan Cancer Hospital
Collaborator