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Combination of Radiation Therapy and Anti-PD-1 Antibody in Treating Patients With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03374293
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Shixiu Wu, Hangzhou Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Radiation Drug: Anti-PD-1 Antibody Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Radiation Therapy With Anti-PD-1 Antibody in Treating Patients With Unresectable Pancreatic Cancer
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Radiation: Radiation
RT 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 .

Drug: Anti-PD-1 Antibody
Anti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes.




Primary Outcome Measures :
  1. Local control [ Time Frame: 2 year ]
    occurrence of local or regional progression


Secondary Outcome Measures :
  1. 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

  2. Objective response rate [ Time Frame: 3 months ]
    Objective response rate as assessed by RECIST criteria

  3. Overall survival [ Time Frame: 2 year ]
    Overall survival



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age:18-75 years, male or female.
  2. Histologically or cytologically confirmed pancreatic cancer.
  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. 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. 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.
  3. Known central nervous system (CNS) metastases.
  4. Subjects with any active autoimmune disease or history of autoimmune disease.
  5. 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;
  6. 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);
  7. History of Interstitial Pneumonia or active non-infectious pneumonitis.
  8. Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
  9. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
  10. 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.
  11. 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.
  12. Received a live vaccine within 4 weeks of the first dose of study medication.
  13. Pregnancy or breast feeding. Decision of unsuitableness by principal investigator or physician-in-charge.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374293


Locations
China, Zhejiang
Hangzhou Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Shixiu Wu, MD    +8657786826086    wushixiu@medmail.com.cn   
Sponsors and Collaborators
Shixiu Wu

Responsible Party: Shixiu Wu, director of the hospital, Hangzhou Cancer Hospital
ClinicalTrials.gov Identifier: NCT03374293     History of Changes
Other Study ID Numbers: HangzhouCH10
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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:
pancreatic cancer
Radiation
Anti-PD-1 Antibody

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs