Clinical trial NCT06346808: Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC
Official title: Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With Borderline Resectable and Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Oncolytic virus
immunotherapy
Preoperative therapy
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: R0 resection rate
timeFrame: 6 months
measure: ORR
timeFrame: 6 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Zhong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: