Verified June 2017 by Shixiu Wu, Hangzhou Cancer Hospital
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Shixiu Wu, Hangzhou Cancer Hospital
First received: June 13, 2017
Last updated: June 13, 2017
Last verified: June 2017
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
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer|
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 3 months ]
Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0
- Objective response rate [ Time Frame: 3 months ]
Objective response rate as assessed by RECIST criteria
- Overall survival [ Time Frame: 1 year ]
|Actual Study Start Date:||June 14, 2017|
|Estimated Study Completion Date:||December 31, 2019|
|Estimated Primary Completion Date:||June 30, 2018 (Final data collection date for primary outcome measure)|
|Experimental: 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.
RT 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.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Senior)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- age:18-75 years, male or femal.
- Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease or Metastatic disease.
- Fail to the first-line standard therapy.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Can provide either a newly obtained or archival tumor tissue sample.
- ECOG 0-1.
- Life expectancy of greater than 12 weeks.
- Adequate organ function.
- 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 or through 180 days after the last dose of docetaxel or irinotecan.
- Patient has given written informed consent.
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- 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.
- Known central nervous system (CNS) metastases.
- Subjects with any active autoimmune disease or history of autoimmune disease.
- 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;
- 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);
- History of Interstitial Pneumonia or active non-infectious pneumonitis.
- Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
- Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation.
- 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.
- 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.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Pregnancy or breast feeding.
- Decision of unsuitableness by principal investigator or physician-in-charge.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03187314
|Hangzhou Cancer Hospital|
|Hangzhou, Zhejiang, China, 310002|
|Contact: Shixiu Wu, MD +8657186826086 firstname.lastname@example.org|
|Contact: Zhao Jing, MD +8657156008656 email@example.com|
Hangzhou Cancer Hospital
Jiangsu HengRui Medicine Co., Ltd.
|Responsible Party:||Shixiu Wu, Professor, Hangzhou Cancer Hospital|
|ClinicalTrials.gov Identifier:||NCT03187314 History of Changes|
|Other Study ID Numbers:||HangzhouCH08|
|Study First Received:||June 13, 2017|
|Last Updated:||June 13, 2017|
|Individual Participant Data|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Keywords provided by Shixiu Wu, Hangzhou Cancer Hospital:
Additional relevant MeSH terms:
Digestive System Diseases
Digestive System Neoplasms
|Neoplasms by Site
Head and Neck Neoplasms
Physiological Effects of Drugs
ClinicalTrials.gov processed this record on June 14, 2017