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

NCT ID: NCT03374293

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-12-31

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

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Radiation

Intervention Type: 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 .

Anti-PD-1 Antibody

Intervention Type: DRUG

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

Interventions

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 .

Intervention Type: RADIATION

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 Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shixiu Wu

OTHER

Sponsor Role: lead

Responsible Party

Shixiu Wu

director of the hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shixiu Wu, MD

Role: primary

wushixiu@medmail.com.cn

+8657786826086

Other Identifiers

HangzhouCH10

Identifier Type: -

Identifier Source: org_study_id