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Trial Title:
Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC
NCT ID:
NCT06346808
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic Cancer
Oncolytic virus
immunotherapy
Preoperative therapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oncolytic virus Plus Anti-PD1 and Chemotherapy
Description:
Oncolytic virus，Camrelizumab ，AG（Gemcitabine +Capecitabine ）
Arm group label:
Oncolytic virus Plus Anti-PD1 and Chemotherapy
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Contact:
Last name:
Zhong Wu, MD
Start date:
May 1, 2024
Completion date:
May 1, 2027
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06346808
