Status:
RECRUITING
Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Hebei Medical University Fourth Hospital
Conditions:
Esophageal Neoplasm Metastatic
Esophageal Cancer Stage IVb
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 AJCC Cancer Staging Manual, 8th Edition) or recurrent patients with recurrence after radical treatment (radical treatment includes surgery and radiotherapy, but the recurrence site cannot be located in the previous radiotherapy field).
- 3\. ECOG performance 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;
- For patients after definitive or preoperative radiotherapy, no recurrence was in the prior radiation filed;
- Expected survival is more than 12 weeks;
- Informed consent provided;
- With response to 2-4 cycles of the first-line chemotherapy combined with immunotherapy.
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 :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 26 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06084897
Start Date
October 16 2023
End Date
October 26 2028
Last Update
June 14 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer hospital, CAMS
Beijing, Beijing Municipality, China, 100021