Status:
UNKNOWN
Combination of Radiation Therapy and Anti-PD-1 Antibody in Treating Patients With Pancreatic Cancer
Lead Sponsor:
Shixiu Wu
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- age:18-75 years, male or female.
- Histologically or cytologically confirmed pancreatic cancer.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Can provide either a newly obtained or archival tumor tissue sample.
- ECOG 0-1.
- Life expectancy of greater than 12 weeks.
- Adequate organ function.
- Patient has given written informed consent.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03374293
Start Date
December 1 2017
End Date
December 31 2021
Last Update
February 10 2021
Active Locations (1)
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1
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China, 310000