Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, Oncolytic virus, immunotherapy, Preoperative therapy
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
Interventions
DRUGOncolytic virus Plus Anti-PD1 and Chemotherapy
Oncolytic virus，Camrelizumab ，AG（Gemcitabine +Capecitabine ）
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Related Adverse Events [Safety and Tolerability] | through study completion, an average of 1 year | Defined by treatment-related adverse events as assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 6 months | defined as complete resection without any macroscopic or microscopic evidence of lesion at the lateral and deep tissue margins |
| ORR | 6 months | The incidence of CR (complete remission) and PR (partial remission) |
Countries
China
Contacts
Primary ContactZhong Wu, MD
Outcome results
None listed