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

Phase 2Not Yet RecruitingNCT06196671

Fudan University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

H101DRUG

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

CamrelizumabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Overall survival，OS

OS of subjects from recruiting to the time of death from any cause

Time frame: At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes

progression-free survival, PFS

PFS of subjects from recruiting to the time of disease progression

Time frame: At the end of Cycle 1 (each cycle is 21 days)

objective response rate (ORR)

CR + PR

Time frame: At the end of Cycle 1 (each cycle is 21 days)

disease control rate (DCR)

CR + PR + SD

Time frame: At the end of Cycle 1 (each cycle is 21 days)

Central Contacts

Ying Yang, MD

CONTACT

86 64175590 yangying@fudanpci.org

Guopei Luo, MD

CONTACT

luoguopei@fudanpci.org

Data from ClinicalTrials.gov

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