Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT03732508
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
2. No previous systemic anti-tumor treatment;
3. Subjects must have at least one measurable tumor lesion per RECIST 1.1;
4. ECOG: 0-1;
5. Adequate organ and bone marrow function;
Exclusion Criteria:
1. Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;
2. Prior therapy as follow:
1. Anti-PD-1 or anti-PD-L1;
2. Any experimental drugs within 4 weeks of the first dose of study medication;
3. Received major operations or serious injuries within 4 weeks of the first dose of study medication;
4. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
4. Subjects with any active autoimmune disease or history of autoimmune disease;
5. Pregnancy or breast feeding;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03732508
Study Brief:
Protocol Section:
NCT03732508