Phase II Study of Radiation Therapy With Anti-PD-1 Antibody in Treating Patients With Unresectable Pancreatic Cancer

Shixiu Wu1 site in 1 country21 target enrollmentDecember 1, 2017

ConditionsPancreatic Cancer

InterventionsRadiation Anti-PD-1 Antibody

DrugsAnti-PD-1 Antibody

Overview

Phase: Phase 2
Intervention: Radiation
Conditions: Pancreatic Cancer
Sponsor: Shixiu Wu
Enrollment: 21
Locations: 1
Primary Endpoint: Local control
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody in patients with pancreatic cancer

Registry

clinicaltrials.gov

Start Date

December 1, 2017

End Date

December 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shixiu Wu

Responsible Party

Sponsor Investigator

Principal Investigator

Shixiu Wu

director of the hospital

Hangzhou Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•age:18-75 years, male or female.
•Histologically or cytologically confirmed pancreatic cancer.
•Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
•Can provide either a newly obtained or archival tumor tissue sample.
•Life expectancy of greater than 12 weeks.
•Adequate organ function.
•Patient has given written informed consent.

Exclusion Criteria

•Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
•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.
•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 treatment. Except: inhalation or topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent for replacement therapy.

Arms & Interventions

Experimental Group

Radiation to 45-50.4 Gy, 5 x per week, 1.8Gy/fx. Radiation begun the day after the first dose of anti-PD-1 antibody . Anti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes.

Intervention: Radiation