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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222440
• Other study ID #: SHR-1210-RT-ESC-IIT
• Status: Completed
• Phase: N/A
• Start date: July 19, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: November 2019
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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。

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2019
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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,?-?a.

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.

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Drug:
• SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Tianjin Medical University Cancer Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Adverse events (AE), Serious Adverse Event(SAE)	Through study completion, an average of half a year
Secondary	ORR	Objective Response Rate	Through study completion, an average of 1 year
Secondary	PFS	Progression-Free Survial	1year and 3years
Secondary	OS	Overall Survival	1year and 3years