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

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

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Esophageal Squamous Cell Cancer
• Intervention / Treatment: Drug: Irinotecan liposome; Drug: SHR-1316; Drug: Fluorouracil

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fei Shi; Phone Number: +86-18036618733; Email: hrshifei@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Cancer Institute and Hospital,Chinese Academy of Medical Science
      • Contact: Jing Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Jing Huang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Neoplasms, Squamous Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Fluorouracil; Irinotecan
• Other Study ID Numbers: IRI-SHR-1316-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No