Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oncolytic virus Plus Anti-PD1 and Chemotherapy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With Borderline Resectable and Locally Advanced Pancreatic Cancer
Overview
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
- Drug Oncolytic virus Plus Anti-PD1 and Chemotherapy
Oncolytic virus，Camrelizumab ，AG（Gemcitabine +Capecitabine ）
Primary outcome measures
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability] [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
- R0 resection rate [Time frame: 6 months]
- ORR [Time frame: 6 months]
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
- Received antitumor chemotherapy, radiation therapy, and immunotherapy prior to first treatment.
- Patients with comorbid severe pancreatic portal hypertension, which may cause a higher risk of bleeding with subsequent injection therapy;
- Patients with prior or concomitant history of other tumors (except basal cell carcinoma of the skin, cervical cancer in situ).
- 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;
- Uncontrollable comorbidities, including, but not limited to, active bacterial, viral, tuberculosis, or fungal infection, symptomatic congestive heart failure, unstable angina, and cardiac arrhythmia.
- Patients with autoimmune disease or immunodeficiency treated with immunosuppressive drugs;
- Pregnant or lactating women;
- Those who may be allergic to the study drug or any of its excipients;
- 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;
- Substance abuse or those who are unable to undergo immunization or lysosomal viral therapy due to clinical, psychological, or social factors.
- Any uncertainty that affects patient safety or compliance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital, Sichuan University — Chengdu
Identifiers
NCT: NCT06346808 · PDAC-OV