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.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Provincial Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Interventional

    Procedure/Surgery

    Pancreatic tumor and liver metastases: TAC Liver metastases: For non-diffuse liver metastases with good blood supply: TACE

  • Targeted Therapy (anti-VEGF)

    Drug

    Apatinib 250 mg qd

  • Immunotherapy + Targeted Therapy

    Drug

    After 1-2 weeks Iparomlimab and Tuvonralimab (50 mg/2 mL) combined with Apatinib 250 mg qd

  • Immunotherapy + Targeted Therapy + Chemotherapy

    Drug

    After 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 intervention

    Interventional 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

38 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival(PFS)

The time from treatment initiation to disease progression or death from any cause in cancer patients.

Time frame
Approximately 1 day after disease progression or death from any cause in cancer patients.

Secondary outcomes

1

Objective Response Rate(ORR)

The proportion of subjects who achieve complete response (CR) and partial response (PR) among the total subjects.

Time frame
Approximately 1 month after imaging examination
2

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).

Time frame
Approximately 1 month after imaging examination
3

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.

Time frame
Approximately 1 day after the time from when the tumor first achieves an objective response (shrinkage or disappearance) to disease progression or death.
4

Overall Survival (OS)

The time from initial treatment to death from any cause

Time frame
Approximately 2 years after last participant enrollment.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: