OncoMatch/Clinical Trials/NCT07006077
Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Pancreatic Cancer
Is NCT07006077 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Recombinant human IL-21-expressing oncolytic vaccinia virus for advanced pancreatic cancer.
Treatment: Recombinant human IL-21-expressing oncolytic vaccinia virus — The main goal of this clinical trial is to preliminary evaluate the efficacy of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced pancreatic cancer.And the secondary purpose is to evaluate the safety of hV01.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy
refractory or failed to respond to standard therapy (including disease progression and/or intolerable toxicities)
Cannot have received: systemic anti-tumor treatment
Systemic anti-tumor treatment, including chemotherapy, large-molecule targeted therapy, immunotherapy, and endocrine therapy within 4 weeks before first dose (within 6 weeks of dosing for nitrosourea or mitomycin C)
Cannot have received: small-molecule targeted therapy
Small-molecule targeted therapy within 2 weeks before first dose or within 5 half-lives of the small-molecule targeted drug (whichever is longer)
Cannot have received: traditional Chinese medicine or Chinese herbal medicine used as anti-tumor agent
Traditional Chinese medicine or Chinese herbal medicine used as anti-tumor agent within 2 weeks before first dose
Cannot have received: radiotherapy
Exception: excluding palliative radiotherapy
Radiotherapy (excluding palliative radiotherapy) within 2 weeks before first dose
Cannot have received: oncolytic virus treatment
Prior oncolytic virus treatment
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥ 1.5×10^9/L, platelet (PLT) count ≥ 75×10^9/L, hemoglobin (Hb) ≥90 g/L (without supportive therapy within 14 days prior to laboratory test)
Kidney function
serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance (Cockcroft-Gault method) ≥45 mL/min
Liver function
serum total bilirubin (TBIL) ≤1.5×ULN (or ≤3×ULN for patients with liver metastasis); AST and ALT ≤3×ULN (or <5×ULN for patients with primary liver cancer or liver metastasis)
Cardiac function
QTc ≤450 ms for males or ≤470 ms for females, NYHA class I, LVEF ≥50%, no severe arrhythmia, no acute coronary syndrome, myocarditis, congestive heart failure, cerebrovascular accidents, or other cardiovascular events of CTCAE (v5.0) grade 3 or higher within 12 months of dosing, no uncontrolled hypertension or hypotension
Required baseline laboratory data include: Hematology: ANC ≥ 1.5×10^9/L, PLT ≥ 75×10^9/L, Hb ≥90 g/L (without supportive therapy within 14 days prior to laboratory test); Liver function: TBIL ≤1.5×ULN (or ≤3×ULN for patients with liver metastasis); AST and ALT ≤3×ULN (or <5×ULN for patients with primary liver cancer or liver metastasis); Renal function: Cr ≤1.5×ULN, and creatinine clearance (Cockcroft-Gault method) ≥45 mL/min; Coagulation: APTT ≤1.5×ULN; INR ≤1.5×ULN. Cardiac: see exclusion criteria for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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