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

Phase 2

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: H101; Drug: Camrelizumab

• Registration Number: NCT06196671
• Lead Sponsor: Fudan University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2023-12-26
• Study First Posted: 2024-01-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Study Start: 2024-12-01
• Primary Completion: 2026-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oncolytic virus plus PD-1 inhibitor	H101	* 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.
Oncolytic virus plus PD-1 inhibitor	Camrelizumab	* 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.

Primary Outcome Measures

Name	Time	Method
Overall survival，OS	At the end of Cycle 1 (each cycle is 21 days)	OS of subjects from recruiting to the time of death from any cause

Secondary Outcome Measures

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