Actively Recruiting
PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-07-16
436
Participants Needed
1
Research Sites
290 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 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.
CONDITIONS
Official Title
PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically or cytologically confirmed squamous cell esophageal cancer at stage IVb with no more than 2 organs affected by distant metastasis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; patients 65 years or older must complete and pass G8 screening or Comprehensive Geriatric Assessment
- Normal routine blood and liver/kidney function test results
- No prior thoracic radiation therapy
- Expected survival longer than 12 weeks
- Provided informed consent
You will not qualify if you...
- History of other cancers except hypopharyngeal carcinoma in situ, non-malignant skin cancer, and cervical carcinoma in situ
- Previous surgery (except ostomy), chemotherapy, or other anti-tumor treatments before enrollment
- Active infection or recent major health events such as myocardial infarction, stroke, or major surgery within 6 months before randomization
- Allergy to chemotherapy drugs or autoimmune disease
- Participation in other clinical trials currently or within 4 weeks before enrollment
- Conditions that pose high risk for fistula making radiotherapy unsafe as judged by a 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
Z
Zhi-Hao Lu, 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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