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

Sichuan University

Status and phase: Not yet enrolling; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Oncolytic virus Plus Anti-PD1 and Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06346808

PDAC-OV

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

1. Received antitumor chemotherapy, radiation therapy, and immunotherapy prior to first treatment.
2. Patients with comorbid severe pancreatic portal hypertension, which may cause a higher risk of bleeding with subsequent injection therapy;
3. Patients with prior or concomitant history of other tumors (except basal cell carcinoma of the skin, cervical cancer in situ).
4. 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;
5. Uncontrollable comorbidities, including, but not limited to, active bacterial, viral, tuberculosis, or fungal infection, symptomatic congestive heart failure, unstable angina, and cardiac arrhythmia.
6. Patients with autoimmune disease or immunodeficiency treated with immunosuppressive drugs;
7. Pregnant or lactating women;
8. Those who may be allergic to the study drug or any of its excipients;
9. 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;
10. Substance abuse or those who are unable to undergo immunization or lysosomal viral therapy due to clinical, psychological, or social factors.
11. Any uncertainty that affects patient safety or compliance.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Oncolytic virus Plus Anti-PD1 and Chemotherapy

Experimental group

Description:

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

Treatment:

Drug: Oncolytic virus Plus Anti-PD1 and Chemotherapy