Clinical trial · Interventional
Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC
Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With Borderline Resectable and Locally Advanced Pancreatic Cancer
NCT06346808CI-TRIAL-00075738not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncolytic virus Plus Anti-PD1 and Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oncolytic virus Plus Anti-PD1 and Chemotherapy
- description
- Oncolytic virus d1 ;Camrelizumab 200mg, d2+AG(Gemcitabine d2/9+Capecitabine d2-d15),q3w;up to 4 cycles;
- interventionNames
- Drug: Oncolytic virus Plus Anti-PD1 and Chemotherapy
Primary outcomes (1)
- measure
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
- timeFrame
- through study completion, an average of 1 year
- description
- Defined by treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcomes (2)
- measure
- R0 resection rate
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.