Oncolytic Virus Plus Anti-PD1 And Chemotherapy As Preoperative Therapy For Patients With BRPC/LAPC

Study Overview

Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer

N/A

Pancreatic Cancer

DRUG: Oncolytic virus Plus Anti-PD1 and Chemotherapy

PDAC-OV

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 2024-03-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-29
First Submitted that Met QC Criteria 2024-03-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-04
First Posted (ACTUAL) 2024-04-04	Results First Posted N/A	Last Verified 2024-03

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: Oncolytic virus Plus Anti-PD1 and Chemotherapy Oncolytic virus d1 ;Camrelizumab 200mg, d2+AG(Gemcitabine d2/9+Capecitabine d2-d15),q3w；up to 4 cycles;	DRUG: Oncolytic virus Plus Anti-PD1 and Chemotherapy Oncolytic virus，Camrelizumab ，AG（Gemcitabine +Capecitabine ）

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Oncolytic virus Plus Anti-PD1 and Chemotherapy

Oncolytic virus d1 ;Camrelizumab 200mg, d2+AG(Gemcitabine d2/9+Capecitabine d2-d15),q3w；up to 4 cycles;

DRUG: Oncolytic virus Plus Anti-PD1 and Chemotherapy

Oncolytic virus，Camrelizumab ，AG（Gemcitabine +Capecitabine ）

Primary Outcome Measures	Measure Description	Time Frame
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]	Defined by treatment-related adverse events as assessed by CTCAE v4.0	through study completion, an average of 1 year

Secondary Outcome Measures	Measure Description	Time Frame
R0 resection rate	defined as complete resection without any macroscopic or microscopic evidence of lesion at the lateral and deep tissue margins	6 months
ORR	The incidence of CR (complete remission) and PR (partial remission)	6 months

Contacts and Locations

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

Study Contact

Name: Zhong Wu, MD

Phone Number: 028-85422851

Email: wuzhong5555@126.com

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.

Investigators

PRINCIPAL_INVESTIGATOR: Zhong Wu, MD, West China Hospital

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

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Resources

PatientS

Caregivers

Clinical Trial Record