Combination of Radiotherapy and SHR-1210 to Treat Patients With ESCC

Not Applicable

Completed

• Conditions: Esophageal Cancer
• Interventions: Drug: SHR-1210

• Registration Number: NCT03222440
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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。

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-17
• Study Start: 2017-07-19
• Study First Posted: 2017-07-19
• Primary Completion: 2018-07-20
• Status Verified: 2019-11
• Study Completion: 2019-11-01
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. age:18-75 years, male or femal.
2. 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.
3. Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. ECOG 0-1.
6. Adequate organ function.
7. Life expectancy of greater than 6 months.
8. Patient has given written informed consent.

Exclusion Criteria

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. 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;
6. 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);
7. Received a live vaccine within 4 weeks of the first dose of study medication.
8. Pregnancy or breast feeding.
9. Decision of unsuitableness by principal investigator or physician-in-charge.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1210+ Radiotherapy	SHR-1210	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Through study completion, an average of half a year	Adverse events (AE), Serious Adverse Event(SAE)

Secondary Outcome Measures

Name	Time	Method
ORR	Through study completion, an average of 1 year	Objective Response Rate
PFS	1year and 3years	Progression-Free Survial
OS	1year and 3years	Overall Survival

Trial Locations

Locations (1)

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China