Actively Recruiting
Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-06-14
120
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 II clinical trial to assess whether radiotherapy could further improve the survival of patients with metastatic esophageal cancer responding to PD-1 Inhibitor plus chemotherapy. 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.
CONDITIONS
Official Title
Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically or cytologically confirmed esophageal squamous cell carcinoma, stage IVb or recurrent after radical treatment not involving previous radiotherapy field
- ECOG performance status of 0 or 1; patients 65 and older must pass G8 screening or comprehensive geriatric assessment
- No significant abnormalities in blood routine or liver and kidney function tests
- No recurrence within prior radiation field for patients with previous definitive or preoperative radiotherapy
- Expected survival time greater than 12 weeks
- Provided informed consent
- Responded to 2 to 4 cycles of first-line chemotherapy combined with immunotherapy
You will not qualify if you...
- History of other cancers except hypopharyngeal carcinoma in situ, non-malignant skin cancer, or cervical carcinoma in situ
- Received surgery (except ostomy), chemotherapy, or other anti-tumor treatments before enrollment
- Active infection currently or major surgery (gastrointestinal, neurological, cardiopulmonary), myocardial infarction, or cerebrovascular accident within 6 months prior to randomization
- History of allergy to chemotherapy drugs or autoimmune diseases
- Participation in other clinical trials currently or within 4 weeks before enrollment
- Conditions posing high risk for safe radiotherapy as assessed by radiation oncologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer hospital, CAMS
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
W
Wen-Yang Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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