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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03732508
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Esophageal Squamous Cell Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 30, 2018
Status verified
Oct 2018
Primary completion
Nov 30, 2019
Completion
Oct 31, 2020

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan liposome plus SHR1316 plus fluorouracil

Primary Outcome Measure

Duration of Progression-Free Survival (PFS) [ Time Frame: approximately 22 months ]

Central Contacts