Oncolytic Virus Plus PD-1 Inhibitor To Patients With Advanced Pancreatic Cancer

Study Overview

Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer

The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to Patients with Advanced Pancreatic Cancer.

Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. Recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. PD-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. Combination of PD-1 blocking antibody plus oncolytic virus may increase anti-tumor efficacy in pancreatic cancer. The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to patients with advanced pancreatic cancer who are refractory to standard chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every three weeks.

Pancreatic Cancer

DRUG: H101
DRUG: Camrelizumab

PTCA199-8

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 2023-12-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-04
First Submitted that Met QC Criteria 2023-12-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-07
First Posted (ACTUAL) 2024-01-09	Results First Posted N/A	Last Verified 2025-03

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 PD-1 inhibitor * H101 intratumorally injection starts at day 1. * Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2. * After two cycles of treatment, Camrelizumab will be administered alone at 200 mg i.v. every 3 weeks from cycle 3 until documented	DRUG: H101 H101 15x10^11vp intratumorally injection starts at day 1. DRUG: Camrelizumab Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Oncolytic virus plus PD-1 inhibitor

* H101 intratumorally injection starts at day 1. * Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2. * After two cycles of treatment, Camrelizumab will be administered alone at 200 mg i.v. every 3 weeks from cycle 3 until documented

DRUG: H101

H101 15x10^11vp intratumorally injection starts at day 1.

DRUG: Camrelizumab

Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.

Primary Outcome Measures	Measure Description	Time Frame
Overall survival，OS	OS of subjects from recruiting to the time of death from any cause	At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcome Measures	Measure Description	Time Frame
progression-free survival, PFS	PFS of subjects from recruiting to the time of disease progression	At the end of Cycle 1 (each cycle is 21 days)
objective response rate (ORR)	CR + PR	At the end of Cycle 1 (each cycle is 21 days)
disease control rate (DCR)	CR + PR + SD	At the end of Cycle 1 (each cycle is 21 days)

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: Ying Yang, MD

Phone Number: 86 64175590

Email: yangying@fudanpci.org

Study Contact Backup

Name: Guopei Luo, MD

Phone Number:

Email: luoguopei@fudanpci.org

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:

Ability to understand and the willingness to sign a written informed consent document.
Age ≥ 18 years and ≤ 80 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
Patients who have received at least two lines of anti-tumor chemotherapy, or patients who have been unsuitable or unwilling to standard therapy.
Locally advanced, or metastatic pancreatic cancer.
Presence of at least of one measurable lesion in agreement to RECIST criteria.
The expected survival ≥ 3 months.
Adequate organ performance based on laboratory blood tests.
Patients who are willing or able to comply with study procedures.

Pregnant or nursing women.
Primary pancreatic cancer, or prior treatment with oncolytic virus and PD-1 inhibitor.
The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
Allergic to study drugs.
Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.

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

Chiu M, Armstrong EJL, Jennings V, Foo S, Crespo-Rodriguez E, Bozhanova G, Patin EC, McLaughlin M, Mansfield D, Baker G, Grove L, Pedersen M, Kyula J, Roulstone V, Wilkins A, McDonald F, Harrington K, Melcher A. Combination therapy with oncolytic viruses and immune checkpoint inhibitors. Expert Opin Biol Ther. 2020 Jun;20(6):635-652. doi: 10.1080/14712598.2020.1729351. Epub 2020 Feb 23.
Zhang Y, Qian L, Chen K, Gu S, Wang J, Meng Z, Li Y, Wang P. Intraperitoneal oncolytic virotherapy for patients with malignant ascites: Characterization of clinical efficacy and antitumor immune response. Mol Ther Oncolytics. 2022 Mar 15;25:31-42. doi: 10.1016/j.omto.2022.03.003. eCollection 2022 Jun 16.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record