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

Esophageal Cancer Clinical Trial

Official title:

A Single Arm Exploratory Study of Chemotherapy Plus Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Locally Advanced Esophageal Squamous Cell Carcinomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03671265
• Other study ID #: SHR-1210-CRT-ESC-IIT
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: August 2018
• 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 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。

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. age:18-75 years, male or female.

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

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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-incharge.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Radiation:
• IMRT or VMAT
The IMRT or VMAT technique was used in our study.

Drug:
• Apatinib
Apatinib is a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2.

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	Adverse events (AE), Serious Adverse Event(SAE) Adverse events	Incidence of Treatment-Emergent Adverse Events	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 Survival	1year and 3years
Secondary	OS	overall survival	1year and 3years