Status:
RECRUITING
PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Beijing Cancer Prevention & Treatment Society
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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, m...
Detailed Description
Esophageal cancer (EC) is one of the most common carcinomas with high morbidity and mortality worldwide. More than 30% of the patients were stage IV when diagnosed. Fluoropyrimidine plus platinum-base...
Eligibility Criteria
Inclusion
- 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;
- There was no significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function;
- No prior history of thoracic radiation;
- Expected survival is more than 12 weeks;
- Informed consent provided.
Exclusion
- Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.
- 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;
- There are factors such as high risk of fistula that radiotherapy cannot be safely carried out as assessed by the radiation oncologist.
Key Trial Info
Start Date :
February 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 28 2029
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT06086457
Start Date
February 4 2024
End Date
August 28 2029
Last Update
July 16 2024
Active Locations (1)
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1
Cancer hospital, CAMS
Beijing, Beijing Municipality, China, 100021