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

NCT03374293 | Unknown Phase 2

• 1 other identifier: HangzhouCH10
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

pancreatic cancer; Radiation; Anti-PD-1 Antibody

Outcome Measures

Primary Outcomes (1)

• Local control

  occurrence of local or regional progression

  2 year

Secondary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events

  3 months

• Objective response rate

  3 months

• Overall survival

  2 year

Study Arms (1)

Experimental Group

EXPERIMENTAL

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; Drug: Anti-PD-1 Antibody

Interventions

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 .

Experimental Group

Anti-PD-1 Antibody DRUG

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shixiu Wu: lead

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiation; spartalizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of the hospital

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 15, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

CN (1)