Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer (PTCA199-8)

March 25, 2024 updated by: Guopei Luo, Fudan University
The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to Patients with Advanced Pancreatic Cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

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

Study Contact Backup

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
  • The following treatment will be applied according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline.
Drug: H101
H101 15x10^11vp intratumorally injection starts at day 1.
Other Names:
  • Oncolytic virus
Drug: Camrelizumab
Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.
Other Names:
  • pd-1 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival，OS
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
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

Outcome Measure
Measure Description
Time Frame
progression-free survival, PFS
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
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)
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
CR + PR
At the end of Cycle 1 (each cycle is 21 days)
disease control rate (DCR)
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
CR + PR + SD
At the end of Cycle 1 (each cycle is 21 days)

Collaborators and Investigators

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

Sponsor

Fudan University

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTCA199-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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