A Multicenter Single-arm Prospective Clinical Study on First-line Treatment of Pancreatic Cancer … (NCT07333287) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Multicenter Single-arm Prospective Clinical Study on First-line Treatment of Pancreatic Cancer Liver Metastases With Arterial Infusion Chemotherapy and Embolization Combined With Dual Immune Checkpoint Inhibitors.
38 participantsStarted 2026-02-01
Plain-language summary
To evaluate the efficacy of arterial infusion chemotherapy and embolization combined with iparplidutol-volerilis (QL1706) as first-line treatment for pancreatic cancer liver metastases based on progression-free survival (PFS).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Absolute neutrophil count (ANC) ≥1.5×10⁹/L (without G-CSF support within 14 days).
✓. Platelets ≥100×10⁹/L (without transfusion within 14 days).
✓. Hemoglobin \>9 g/dL (without transfusion or erythropoietin use within 14 days).
✓. Adequate coagulation function, defined as INR or PT ≤1.5×ULN.
✓. Normal thyroid function, defined as TSH within normal range. If baseline TSH is abnormal, patients may still be enrolled if total T3 (or FT3) and FT4 are within normal limits.
Exclusion criteria
✕. Diagnosis of another malignancy within 5 years prior to the first dose, unless cured (exceptions include radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection).
✕. Currently participating in an interventional clinical study or having received other investigational drugs or devices within 4 weeks prior to the first dose.
✕. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
What they're measuring
1
Progression-Free Survival（PFS）
Timeframe: Approximately 1 day after disease progression or death from any cause in cancer patients.
. Poor tumor blood supply as observed during selective arterial catheterization and angiography of pancreatic tumors and liver metastases.
✕. Systemic treatment with Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs within 2 weeks prior to the first dose.
✕. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.
✕. Current systemic corticosteroid therapy (excluding nasal sprays, inhalational, or other local corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose.
✕. Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.