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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03732508
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Esophageal Squamous Cell Cancer	Drug: Irinotecan liposome; Drug: SHR-1316; Drug: Fluorouracil	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Nov 1, 2018
• Anticipated Primary Completion Date: Nov 1, 2019
• Anticipated Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Irinotecan liposome plus SHR1316 plus fluorouracil	Drug: Irinotecan liposome; Irinotecan liposome intravenous infusion will be administered during the first day of treatment.; Drug: SHR-1316; SHR-1316 intravenous infusion will be administered during the first day of treatment.; Drug: Fluorouracil; Fluorouracil intravenous infusion will be administered during the first day of treatment.

Outcome Measures

Primary Outcome Measures

1. 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

1. Disease Control Rate(DCR) [approximately 22 months]

   based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

2. Objective Response Rate(ORR) [approximately 22 months]

   based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

3. 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.

4. Adverse Events(AE) [approximately 22 months]

   adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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:

3. Anti-PD-1 or anti-PD-L1;

4. Any experimental drugs within 4 weeks of the first dose of study medication;

5. Received major operations or serious injuries within 4 weeks of the first dose of study medication;

6. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;

7. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;

8. Subjects with any active autoimmune disease or history of autoimmune disease;

9. Pregnancy or breast feeding;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute and Hospital,Chinese Academy of Medical Science	Beijing	Beijing	China	100000

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

• Principal Investigator: Jing Huang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03732508
• Other Study ID Numbers: IRI-SHR-1316-201
• First Posted: Nov 6, 2018
• Last Update Posted: Nov 6, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Fluorouracil; Irinotecan

Study Results

No Results Posted as of Nov 6, 2018