Last updated: February 9, 2021
Sponsor: Shixiu Wu
Overall Status: Active - Recruiting
Phase
2
Condition
Pancreatic Disorders
Pancreatitis
Pancreatic Cancer
Treatment
N/AClinical Study ID
NCT03374293
HangzhouCH10
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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) 1.1.
- 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
Exclusion Criteria:
- Patients who have or are currently undergoing additional chemotherapy, radiationtherapy, targeted therapy or immunotherapy.
- Other malignancy within 5 years prior to entry into the study, expect for curativelytreated basal cell and squamous cell carcinoma of the skin and/or curatively resectedin-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 thefollowing: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardialinfarction within the past 1 year; (4) clinically significant supraventriculararrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- Active infection or an unexplained fever > 38.5°C during screening or before the firstscheduled day of dosing (subjects with tumor fever may be enrolled at the discretionof 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 orequivalent dose) or other systematic immunosuppressive medications within 14 daysbefore the study treatment. Except: inhalation or topical corticosteroids. Doses > 10mg/day prednisone or equivalent for replacement therapy.
- Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted smallmolecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or notrecovered 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 orphysician-in-charge.
Study Design
Total Participants: 21
Study Start date:
December 01, 2017
Estimated Completion Date:
December 31, 2021
Connect with a study center
Hangzhou Cancer Hospital
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting
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