SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer

Study Overview
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Brief Summary
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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.

Official Title
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SHR-1316, a Novel Anti-PD-L1 Antibody, in Combination With Irinotecan Liposome and Fluorouracil in Patients With Esophageal Squamous Cell Cancer: a Phase II Study

Conditions
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Advanced Esophageal Squamous Cell Cancer

Intervention / Treatment
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* Drug: Irinotecan liposome
* Drug: SHR-1316
* Drug: Fluorouracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma; No previous systemic anti-tumor treatment; Subjects must have at least one measurable tumor lesion per RECIST 1.1; ECOG: 0-1; Adequate organ and bone marrow function; Exclusion Criteria: Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ; Prior therapy as follow: Anti-PD-1 or anti-PD-L1; Any experimental drugs within 4 weeks of the first dose of study medication; Received major operations or serious injuries within 4 weeks of the first dose of study medication; Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication; Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment; Subjects with any active autoimmune disease or history of autoimmune disease; Pregnancy or breast feeding;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irinotecan liposome plus SHR1316 plus fluorouracil<br> | Drug: Irinotecan liposome<br>* Irinotecan liposome intravenous infusion will be administered during the first day of treatment.<br>Drug: SHR-1316<br>* SHR-1316 intravenous infusion will be administered during the first day of treatment.<br>Drug: Fluorouracil<br>* Fluorouracil intravenous infusion will be administered during the first day of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Progression-Free Survival (PFS) | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate(DCR) | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months | 
| Objective Response Rate(ORR) | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months | 
| Overall Survival(OS) | OS is defined as the time from registration to death due to any cause, or censored at date last known alive. | approximately 22 months | 
| Adverse Events(AE) | adverse events | approximately 22 months |