About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.
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).
Disqualifiers
**Subjects meeting any of the following criteria will be excluded from this study:**
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).
Trial design
Single group
Treatments tested in this trial
Interventional
Procedure/SurgeryPancreatic tumor and liver metastases: TAC Liver metastases: For non-diffuse liver metastases with good blood supply: TACE
Targeted Therapy (anti-VEGF)
DrugApatinib 250 mg qd
Immunotherapy + Targeted Therapy
DrugAfter 1-2 weeks Iparomlimab and Tuvonralimab (50 mg/2 mL) combined with Apatinib 250 mg qd
Immunotherapy + Targeted Therapy + Chemotherapy
DrugAfter 3 weeks Iparomlimab and Tuvonralimab (50 mg/2 mL) on day 1 Albumin-bound paclitaxel 125 mg/m² on days 2 and 9 Gemcitabine 1000 mg/m² on days 2 and 9 Apatinib 250 mg qd
This cycle is repeated every 21 days.
Other interventionInterventional therapy is discontinued if imaging shows no enhancement of tumor vessels and is resumed only upon disease progression or until intolerable adverse reactions occur.
Treatment groups
Trial outcomes
Primary outcomes
Progression-Free Survival(PFS)
The time from treatment initiation to disease progression or death from any cause in cancer patients.
Secondary outcomes
Objective Response Rate(ORR)
The proportion of subjects who achieve complete response (CR) and partial response (PR) among the total subjects.
Disease Control Rate(DCR)
The proportion of patients with tumor shrinkage or stabilization maintained for a certain duration, including those with complete response (CR), partial response (PR), and stable disease (SD).
Duration of Response(DOR)
The period from when a patient achieves an objective response (shrinkage or disappearance of the tumor) after treatment to disease progression or death.
Overall Survival (OS)
The time from initial treatment to death from any cause
Locations
Sponsors and contacts
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