Combination of Chemotherapy Plus RT and SHR-1210 to Treat Patients With ESCC

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT03671265
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • SHR-1210 — DRUG
    SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
  • IMRT or VMAT — RADIATION
    The IMRT or VMAT technique was used in our study.
  • Apatinib — DRUG
    Apatinib is a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2.

Study Details

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an openlabel，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 and chemotherapy in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。

Key Dates

Start date
Sep 17, 2018
Status verified
Aug 2018
Primary completion
Sep 1, 2019
Completion
Sep 1, 2021

Study Design

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

Arms

  • Experimental: SHR-1210 + Chemotherapy + Radiotherapy
    Radiotherapy(IMRT or VMAT): 95%PTV 54Gy/30 fraction,95%PTV 60Gy/30 fraction ,5 fractions per week, for 6 weeks. Radiation begun the day on which first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks, one cycle is four weeks, total 8 cycles ) will be administered as an intravenous infusion over 30 minutes. Chemotherapy: Docetaxel 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22, total 4 cycles; Cisplatin 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22;, total 4 cycles. Apatinib: 250mg/d，PO Qd(4 weeks after Radiotherapy, until the end of 8th ycle )

Primary Outcome Measure

Adverse events (AE), Serious Adverse Event(SAE) Adverse events [ Time Frame: Through study completion, an average of half a year] ]

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