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

NCT06196671 | Not Yet Recruiting Phase 2

• 1 other identifier: PTCA199-8
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• progression-free survival, PFS

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

• objective response rate (ORR)

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

• disease control rate (DCR)

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

Study Arms (1)

Oncolytic virus plus PD-1 inhibitor

EXPERIMENTAL

* 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; Drug: Camrelizumab

Interventions

H101 DRUG

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

Also known as: Oncolytic virus

Oncolytic virus plus PD-1 inhibitor

Camrelizumab DRUG

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

Also known as: pd-1 inhibitor

Oncolytic virus plus PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Related 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 and immune checkpoint inhibitors. Expert Opin Biol Ther. 2020 Jun;20(6):635-652. doi: 10.1080/14712598.2020.1729351. Epub 2020 Feb 23.

  PMID: 32067509 BACKGROUND

• 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.

  PMID: 35399603 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oncolytic Virotherapy; camrelizumab; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Ying Yang, MD

CONTACT

86 64175590; yangying@fudanpci.org

Guopei Luo, MD

CONTACT

luoguopei@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Oncolytic virus plus PD-1 inhibitor

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-03