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

Advanced Esophageal Squamous Cell Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03732508
• Other study ID #: IRI-SHR-1316-201
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2018
• Est. completion date: October 2020

Study information

• Verified date: October 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Fei Shi
• Phone: +86-18036618733
• Email: hrshifei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Esophageal Squamous Cell Cancer
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Neoplasms, Squamous Cell

Intervention

Drug:
• Irinotecan liposome
Irinotecan liposome intravenous infusion will be administered during the first day of treatment.
• SHR-1316
SHR-1316 intravenous infusion will be administered during the first day of treatment.
• Fluorouracil
Fluorouracil intravenous infusion will be administered during the first day of treatment.

Locations

Country	Name	City	State
China	Cancer Institute and Hospital,Chinese Academy of Medical Science	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Progression-Free Survival (PFS)	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	approximately 22 months
Secondary	Disease Control Rate(DCR)	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	approximately 22 months
Secondary	Objective Response Rate(ORR)	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	approximately 22 months
Secondary	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
Secondary	Adverse Events(AE)	adverse events	approximately 22 months