Combination Of Radiation Therapy And Anti-PD-1 Antibody In Treating Patients With Pancreatic Cancer

Study Overview

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

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

N/A

Pancreatic Cancer

RADIATION: Radiation
DRUG: Anti-PD-1 Antibody

HangzhouCH10

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-12-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-02-09
First Submitted that Met QC Criteria 2017-12-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-02-10
First Posted (ACTUAL) 2017-12-15	Results First Posted N/A	Last Verified 2021-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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.

Participant Group/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	Measure Description	Time Frame
Local control	occurrence of local or regional progression	2 year

Secondary Outcome Measures	Measure Description	Time Frame
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
Objective response rate	Objective response rate as assessed by RECIST criteria	3 months
Overall survival	Overall survival	2 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record