A Single Arm Exploratory Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Locally Advanced Esophageal Squamous Cell Carcinomas
Overview
- Phase
- Not Applicable
- Intervention
- SHR-1210
- Conditions
- Esophageal Cancer
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an open-label，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal 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 in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。
Investigators
Eligibility Criteria
Inclusion Criteria
- •age:18-75 years, male or femal.
- •Histologically confirmed primary Squamous Cell Carcinoma of the Esophagus,Local advanced esophageal cancer diagnosed by pathology and imaging,clinical stage T3-4N0M0, T1-4N+M0,Ⅱ-Ⅳa.
- •Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
- •Adequate organ function.
- •Life expectancy of greater than 6 months.
- •Patient has given written informed consent.
Exclusion Criteria
- •Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- •Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
- •Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
- •Subjects with any active autoimmune disease or history of autoimmune disease
- •Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- •Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
- •Received a live vaccine within 4 weeks of the first dose of study medication.
- •Pregnancy or breast feeding.
- •Decision of unsuitableness by principal investigator or physician-in-charge.
Arms & Interventions
SHR-1210+ Radiotherapy
Radiotherapy,intensity modulated radiation therapy (IMRT), 54-60 Gy, 1.8-2.0 Gy per fraction ,5 fractions per week, for 6 weeks. Radiation begun the day after the 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.
Intervention: SHR-1210
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events
Time Frame: Through study completion, an average of half a year
Adverse events (AE), Serious Adverse Event(SAE)
Secondary Outcomes
- ORR(Through study completion, an average of 1 year)
- PFS(1year and 3years)
- OS(1year and 3years)