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

Phase 2

• Conditions: Advanced Esophageal Squamous Cell Cancer
• Interventions: Drug: Irinotecan liposome; Drug: SHR-1316; Drug: Fluorouracil

• Registration Number: NCT03732508
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-31
• Study Start: 2018-11
• Study First Submitted QC: 2018-11-05
• Last Update Submitted: 2018-11-05
• Study First Posted: 2018-11-06
• Last Update Posted: 2018-11-06
• Primary Completion: 2019-11
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irinotecan liposome plus SHR1316 plus fluorouracil	Irinotecan liposome	-
Irinotecan liposome plus SHR1316 plus fluorouracil	SHR-1316	-
Irinotecan liposome plus SHR1316 plus fluorouracil	Fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Duration of Progression-Free Survival (PFS)	approximately 22 months	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer Institute and Hospital,Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China