Advanced Esophageal Squamous Cell Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell cancer.
Interventions
Irinotecan liposome intravenous infusion will be administered during the first day of treatment.
DRUGSHR-1316
SHR-1316 intravenous infusion will be administered during the first day of treatment.
DRUGFluorouracil
Fluorouracil intravenous infusion will be administered during the first day of treatment.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Progression-Free Survival (PFS) | approximately 22 months | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate(DCR) | approximately 22 months | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| Objective Response Rate(ORR) | approximately 22 months | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| Overall Survival(OS) | approximately 22 months | OS is defined as the time from registration to death due to any cause, or censored at date last known alive. |
| Adverse Events(AE) | approximately 22 months | adverse events |
Countries
China
Contacts
Primary ContactFei Shi
Outcome results
None listed