An interventional study of SHR-1210 and IMRT or VMAT in Esophageal Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment
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。
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 20 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects with any active autoimmune disease or history of autoimmune disease
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 )
Drug: SHR-1210 · Radiation: IMRT or VMAT · Drug: Apatinib
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Also known as: Anti-PD-1 Antibody
The IMRT or VMAT technique was used in our study.
Apatinib is a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2.
Adverse events (AE), Serious Adverse Event(SAE) Adverse events
Incidence of Treatment-Emergent Adverse Events
Time frame: Through study completion, an average of half a year]
ORR
Objective Response Rate
Time frame: Through study completion, an average of 1 year
PFS
Progression-Free Survival
Time frame: 1year and 3years
OS
overall survival
Time frame: 1year and 3years
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital