SHR-1210 in Combination With Apatinib and Chemotherapy in Patients With Advanced Esophageal Squamous Cell Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT03603756
Phase
PHASE2
Status
Unknown

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-1210 — DRUG
    a novel anti-PD-1 antibody
  • Apatinib — DRUG
    a VEGFR-2 tyrosine kinase inhibitor
  • Irinotecan Injection — DRUG
    cytotoxic agent that binds to topoisomerase I
  • Paclitaxel liposome — DRUG
    cytotoxic agent that prevent depolymerization of cellular microtubules
  • Nedaplatin — DRUG
    cytotoxic agent that cross-links and denatures strands of DNA

Study Details

Patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma are recruited to this prospective non-randomized study comprising two separate cohorts. Patients will receive SHR-1210, a novel anti-PD-1 antibody, with apatinib and either irinotecan or paclitaxel liposome plus nedaplatin. The primary endpoint is to determine the objective response rate (ORR) of patients in both cohorts. The regimen(s) of promising efficacy will be further verified in subsequent randomized studies to define the optimal combination of immunotherapy, anti-angiogenesis and chemotherapy in advanced esophageal cancer patients.

Key Dates

Start date
Jul 31, 2018
Status verified
Feb 2020
Primary completion
Mar 28, 2020
Completion
Mar 28, 2021

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patients with advanced or metastatic esophageal squamous cell carcinoma are to receive SHR-1210 with apatinib and irinotecan injection in cohort 1.
  • Experimental: Cohort 2
    Patients with advanced or metastatic esophageal squamous cell carcinoma are to receive SHR-1210 with apatinib and paclitaxel liposome plus nedaplatin in cohort 2.

Primary Outcome Measure

objective response rate [ Time Frame: 24 months ]

Central Contacts

Related Studies