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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03374293
• Other study ID #: HangzhouCH10
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Hangzhou Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shixiu Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control	occurrence of local or regional progression	2 year
Secondary	Incidence of Treatment-Emergent Adverse Events	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	3 months
Secondary	Objective response rate	Objective response rate as assessed by RECIST criteria	3 months
Secondary	Overall survival	Overall survival	2 year