Combination of Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Esophageal Cancer

NCT ID: NCT03187314

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2019-06-30

Brief Summary

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 esophageal cancer

Conditions

Esophageal Neoplasms; Esophageal Diseases; Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Radiation to 60 Gy, 5 x per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.

Group Type: EXPERIMENTAL

Radiation

Intervention Type: DRUG

RT to 60 Gy, 5 x per week，for 6 weeks. Radiation begun the day after the first dose of SHR-1210

SHR-1210

Intervention Type: DRUG

SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.

Interventions

Radiation

RT to 60 Gy, 5 x per week，for 6 weeks. Radiation begun the day after the first dose of SHR-1210

Intervention Type: DRUG

SHR-1210

SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease.

3. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

4. Can provide either a newly obtained or archival tumor tissue sample.

5. ECOG 0-1.

6. Life expectancy of greater than 12 weeks.

7. Adequate organ function.

8. Female: child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 3 months after the last dose of SHR-1210.

9. 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. Complete obstruction of the esophagus, or patients who have the potential to develop perforation

3. Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.

4. Known central nervous system (CNS) metastases.

5. Subjects with any active autoimmune disease or history of autoimmune disease.

6. 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;

7. 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);

8. History of Interstitial Pneumonia or active non-infectious pneumonitis.

9. Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.

10. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.

11. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation.

12. Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treament. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalen for replacement therapy.

13. Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.

14. Received a live vaccine within 4 weeks of the first dose of study medication.

15. Pregnancy or breast feeding.

16. Decision of unsuitableness by principal investigator or physician-in-charge.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Hangzhou Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shixiu Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

HangzhouCH08

Identifier Type: -

Identifier Source: org_study_id