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

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced esophageal cancer, specifically stage IVb, which means the cancer has spread to distant parts of the body. Researchers want to find out if combining chemotherapy with a type of immunotherapy called a PD-1 inhibitor, and adding radiation therapy, can help patients live longer compared to chemotherapy and immunotherapy alone.

To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma of the esophagus that has spread to no more than two other organs. You should also be in relatively good health and able to perform daily activities. Participants will receive the study treatment and will have samples taken for testing to help researchers understand how the treatment works and who might benefit most. If you're considering joining, you'll need to provide informed consent, meaning you understand the study and agree to participate.

Gender

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Eligibility 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.