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

NCT ID: NCT06346808

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-05-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oncolytic virus Plus Anti-PD1 and Chemotherapy

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

Group Type: EXPERIMENTAL

Oncolytic virus Plus Anti-PD1 and Chemotherapy

Intervention Type: DRUG

Oncolytic virus，Camrelizumab ，AG（Gemcitabine +Capecitabine ）

Interventions

Oncolytic virus Plus Anti-PD1 and Chemotherapy

Oncolytic virus，Camrelizumab ，AG（Gemcitabine +Capecitabine ）

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Zhen-Yu Ding

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhong Wu, MD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Zhong Wu, MD

Role: CONTACT

wuzhong5555@126.com

028-85422851

Facility Contacts

Zhong Wu, MD

Role: primary

Other Identifiers

PDAC-OV

Identifier Type: -

Identifier Source: org_study_id