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

NCT03732508 | Unknown Phase 2

• 1 other identifier: IRI-SHR-1316-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Esophageal Squamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Duration of Progression-Free Survival (PFS)

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

  approximately 22 months

Secondary Outcomes (4)

• Disease Control Rate(DCR)

  approximately 22 months

• Objective Response Rate(ORR)

  approximately 22 months

• Overall Survival(OS)

  approximately 22 months

• Adverse Events(AE)

  approximately 22 months

Study Arms (1)

Irinotecan liposome plus SHR1316 plus fluorouracil

EXPERIMENTAL

Drug: Irinotecan liposome; Drug: SHR-1316; Drug: Fluorouracil

Interventions

Irinotecan liposome DRUG

Irinotecan liposome intravenous infusion will be administered during the first day of treatment.

Irinotecan liposome plus SHR1316 plus fluorouracil

SHR-1316 DRUG

SHR-1316 intravenous infusion will be administered during the first day of treatment.

Irinotecan liposome plus SHR1316 plus fluorouracil

Fluorouracil DRUG

Fluorouracil intravenous infusion will be administered during the first day of treatment.

Irinotecan liposome plus SHR1316 plus fluorouracil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Cancer Institute and Hospital,Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Interventions

irinotecan sucrosofate; Fluorouracil

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jing Huang

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Shi

CONTACT

+86-18036618733; hrshifei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 6, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: October 1, 2020
• Last Updated: November 6, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)