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.

NCT07333287 | Not Yet Recruiting Phase 2

• 1 other identifier: NO.2025-1074
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Pancreatic Cancer Liver Metastases; Immunotherapy-naive

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival（PFS）

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

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

Secondary Outcomes (5)

• Objective Response Rate（ORR）

  Approximately 1 month after imaging examination

• Disease Control Rate（DCR）

  Approximately 1 month after imaging examination

• Duration of Response（DOR）

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

• Overall Survival (OS)

  Approximately 2 years after last participant enrollment.

• Adverse Event (AE)

  Approximately 2 month after any treatment

Study Arms (1)

Experimental

EXPERIMENTAL

Interventional Combined Targeted Therapy、 Immunotherapy + Targeted Therapy、Immunotherapy + Targeted Therapy + Chemotherapy

Procedure: Interventional; Drug: Targeted Therapy (anti-VEGF); Drug: Immunotherapy + Targeted Therapy; Drug: Immunotherapy + Targeted Therapy + Chemotherapy; Other: This cycle is repeated every 21 days.

Interventions

Interventional PROCEDURE

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

Experimental

Targeted Therapy (anti-VEGF) DRUG

Apatinib 250 mg qd

Experimental

Immunotherapy + Targeted Therapy DRUG

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

Experimental

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

Experimental

This cycle is repeated every 21 days. OTHER

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.
• \. Male or female, aged 18 to 75 years. 3. ECOG performance status score of 0 to 1. 4. Expected survival ≥ 3 months. 5. Histologically or cytologically confirmed, previously untreated unresectable pancreatic ductal adenocarcinoma with liver metastases (TNM stage: IV).
• \. No local treatment (including transarterial chemoembolization/TACE, hepatic arterial infusion chemotherapy/HAIC, radiotherapy, radioembolization, or ablation, etc.) on target lesions within 28 days before the first dose of the study drug.
• \. Recovery from toxicities caused by prior therapies: ≥4 weeks since prior cytotoxic drugs, radiotherapy, or surgery, with wounds fully healed.
• \. No prior treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or CAR-T cell therapy.
• \. Adequate organ function must be confirmed within 28 days before the first dose (without transfusion or use of blood products, G-CSF, or other hematopoietic growth factors for correction within 14 days prior to laboratory tests):
• 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).
• Total bilirubin ≤1.5×ULN.
• AST and ALT ≤2.5×ULN.
• Serum creatinine ≤1.5×ULN and calculated creatinine clearance (Cockcroft-Gault formula) ≥60 mL/min.
• 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.
• Cardiac enzymes within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are allowed).

You may not qualify if:

• \*\*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).
• 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.
• Note:\*\* Physiological doses of corticosteroids (e.g., ≤10 mg/day prednisone or equivalent) are permitted.
• Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
• Known hypersensitivity to iparomlimab and tuvonralimab or any excipients of the combined chemotherapy drugs used in this study.
• Insufficient recovery from toxicities and/or complications of prior interventions (i.e., not recovered to ≤ Grade 1 or baseline, excluding fatigue or alopecia) before starting treatment.
• Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies).
• Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number above the upper limit of normal \[ULN\] at the local laboratory).
• Note:\*\* Subjects with hepatitis B meeting the following criteria may be enrolled:

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Related Publications (1)

• Maekawa A, Omiya K, Oba A, Inoue Y, Hirose Y, Kobayashi K, Ono Y, Sato T, Sasaki T, Ozaka M, Matsueda K, Mise Y, Takamatsu M, Shigematsu Y, Ito H, Saiura A, Sasahira N, Takahashi Y. Clinical implications of disappearing pancreatic cancer liver metastases: Lessons from colorectal liver metastases. Eur J Surg Oncol. 2025 May;51(5):109635. doi: 10.1016/j.ejso.2025.109635. Epub 2025 Jan 27.

  PMID: 39879814 RESULT

MeSH Terms

Interventions

Methods; Immunotherapy; Drug Therapy

Intervention Hierarchy (Ancestors)

Investigative Techniques; Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Dan Sha

CONTACT

+86 13573175130; shadan@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: January 12, 2026

Record last verified: 2025-12