Clinical trial NCT03187314: Combination of Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Esophageal Cancer
Official title: Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Neoplasms
Esophageal Diseases
Esophageal Squamous Cell Carcinoma
Keywords: Esophageal Squamous Cell Carcinoma
Radiation
Anti-PD-1 Antibody
Lead sponsor: Hangzhou Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2017-06-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 4-8 weeks
Secondary outcomes:
measure: Treatment-emergent adverse events
timeFrame: year 0 - year 1
measure: Local-regional free survival (LRFS)
timeFrame: year 0 - year 3
measure: Overall survival
timeFrame: year 0 - year 3
measure: Health-related quality of life (HRQoL)
timeFrame: From baseline to one year after RT.
measure: Health-related quality of life (HRQoL)
timeFrame: From baseline to one year after RT.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
Study officials:
References: