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

Pancreatic Cancer Clinical Trial

— PTCA199-8  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06196671
• Other study ID #: PTCA199-8
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: March 2024
• Source: Fudan University
• Contact: Ying Yang, MD
• Phone: 86 64175590
• Email: yangying[@]fudanpci.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• H101
H101 15x10^11vp intratumorally injection starts at day 1.
• Camrelizumab
Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

References & Publications (2)

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	objective response rate (ORR)	CR + PR	At the end of Cycle 1 (each cycle is 21 days)
Secondary	disease control rate (DCR)	CR + PR + SD	At the end of Cycle 1 (each cycle is 21 days)