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

Pancreatic Cancer Clinical Trial

Official title:

Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With Borderline Resectable and Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346808
• Other study ID #: PDAC-OV
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: March 2024
• Source: Sichuan University
• Contact: Zhong Wu, MD
• Phone: 028-85422851
• Email: wuzhong5555[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Oncolytic virus Plus Anti-PD1 and Chemotherapy
Oncolytic virus,Camrelizumab ,AG(Gemcitabine +Capecitabine )

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	R0 resection rate	defined as complete resection without any macroscopic or microscopic evidence of lesion at the lateral and deep tissue margins	6 months
Secondary	ORR	The incidence of CR (complete remission) and PR (partial remission)	6 months