Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC

NCT06346808 | Not Yet Recruiting Phase 1

• 1 other identifier: PDAC-OV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Oncolytic virus; immunotherapy; Preoperative therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

  Defined by treatment-related adverse events as assessed by CTCAE v4.0

  through study completion, an average of 1 year

Secondary Outcomes (2)

• R0 resection rate

  6 months

• ORR

  6 months

Study Arms (1)

Oncolytic virus Plus Anti-PD1 and Chemotherapy

EXPERIMENTAL

Oncolytic virus d1 ;Camrelizumab 200mg, d2+AG(Gemcitabine d2/9+Capecitabine d2-d15),q3w；up to 4 cycles;

Drug: Oncolytic virus Plus Anti-PD1 and Chemotherapy

Interventions

Oncolytic virus Plus Anti-PD1 and Chemotherapy DRUG

Oncolytic virus，Camrelizumab ，AG（Gemcitabine +Capecitabine ）

Oncolytic virus Plus Anti-PD1 and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age ≥18 years and age ≤75 years. ECOG score 0-1. Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer
• Adequate bone marrow and organ function:
• Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
• Signed informed consent. Ability to comply with the study protocol and follow-up.

You may not qualify if:

• Received antitumor chemotherapy, radiation therapy, and immunotherapy prior to first treatment.
• Patients with comorbid severe pancreatic portal hypertension, which may cause a higher risk of bleeding with subsequent injection therapy;
• Patients with prior or concomitant history of other tumors (except basal cell carcinoma of the skin, cervical cancer in situ).
• Serious uncontrolled medical conditions that may interfere with the subject's ability to receive treatment as specified in the protocol, including, but not limited to, positive HIV test, active tuberculosis, and DNA copy number of HBV \>103/ml;
• Uncontrollable comorbidities, including, but not limited to, active bacterial, viral, tuberculosis, or fungal infection, symptomatic congestive heart failure, unstable angina, and cardiac arrhythmia.
• Patients with autoimmune disease or immunodeficiency treated with immunosuppressive drugs;
• Pregnant or lactating women;
• Those who may be allergic to the study drug or any of its excipients;
• Preoperative ultrasound evaluation of patients with small tumor size, location near or behind major blood vessels, and various other factors that may result in a low success rate of intra-tumoral viral injection under ultrasound and a high rate of post-injection complications;
• Substance abuse or those who are unable to undergo immunization or lysosomal viral therapy due to clinical, psychological, or social factors.
• Any uncertainty that affects patient safety or compliance.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhong Wu, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong Wu, MD

CONTACT

028-85422851; wuzhong5555@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)