Pancreatic Cancer Liver MetastasesPhase 2NCT07333287

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.

A Phase 2 study testing Interventional, Targeted Therapy (anti-VEGF) and Immunotherapy + Targeted Therapy in people with Pancreatic Cancer Liver Metastases and Immunotherapy-naive, run by Shandong Provincial Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pancreatic Cancer Liver Metastases, Immunotherapy-naive
What is being tested?: Interventional, Targeted Therapy (anti-VEGF) and Immunotherapy + Targeted Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: No sites listed yet
Study dates: 1 Feb 2026to 30 Nov 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.
2. 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).
6. Must have measurable lesions according to RECIST 1.1 criteria. 7. No prior systemic therapy for pancreatic cancer or liver metastases, including chemotherapy, targeted therapy, or immunotherapy. (Note: Patients who received only one prior cycle of treatment, or oral targeted/chemotherapy agents for a cumulative duration ≤ 14 days, or those with recurrence more than six months after completing adjuvant chemotherapy may be considered for inclusion.) 8. Selective arterial catheterization and angiography demonstrate staining of pancreatic tumors and liver metastases. Patients with good tumor blood supply are eligible for this study.
9. 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.
10. Recovery from toxicities caused by prior therapies: ≥4 weeks since prior cytotoxic drugs, radiotherapy, or surgery, with wounds fully healed.
11. No prior treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or CAR-T cell therapy.

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12. 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).
13. Males and females of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until at least 5 months (for females) or 7 months (for males) after the last dose of the study drug. Women of childbearing potential must not be pregnant or breastfeeding.

Who cannot join

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.

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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:
HBV viral load < 1000 copies/mL (200 IU/mL) prior to the first dose. The subject must receive anti-HBV therapy throughout the study chemotherapy treatment period to prevent viral reactivation.
Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have undetectable HBV viral load do not require prophylactic anti-HBV therapy but require close monitoring for viral reactivation.
Active HCV infection (HCV antibody positive with HCV-RNA levels above the lower limit of detection).
Administration of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1).
Note:** Inactivated seasonal influenza vaccines administered by injection are permitted within 30 days prior to the first dose. However, live attenuated influenza vaccines administered intranasally are not permitted.
Pregnant or breastfeeding women.
Any severe or uncontrolled systemic disease, such as:
Resting ECG showing significant and symptomatic abnormalities in rhythm, conduction, or morphology (e.g., complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmia, or atrial fibrillation).
Unstable angina, congestive heart failure, or chronic heart failure of New York Heart Association (NYHA) Class ≥2.
Myocardial infarction within 6 months prior to enrollment.
Poorly controlled hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg).
History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease.
Active pulmonary tuberculosis.
Active or uncontrolled infection requiring systemic therapy.
Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
Liver diseases such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.
Poorly controlled diabetes (fasting blood glucose >10 mmol/L).
Urinalysis showing protein ≥++ and confirmed 24-hour urine protein >1.0 g.
Psychiatric disorders that may interfere with treatment compliance.
Any medical history, condition, treatment, or laboratory abnormality that, in the investigator's judgment, may interfere with the trial results, prevent the subject from completing the study, or pose other potential risks making the subject unsuitable for participation.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dan Sha contact

+86 13573175130

shadan@sdfmu.edu.cn

About this study

Conditions: Pancreatic Cancer Liver Metastases, Immunotherapy-naive
Being tested: Interventional, Targeted Therapy (anti-VEGF), Immunotherapy + Targeted Therapy, Immunotherapy + Targeted Therapy + Chemotherapy, This cycle is repeated every 21 days.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InterventionalProcedure or 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 TherapyDrug
After 1-2 weeks Iparomlimab and Tuvonralimab (50 mg/2 mL) combined with Apatinib 250 mg qd
Immunotherapy + Targeted Therapy + ChemotherapyDrug
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
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.

Study groups in NCT07333287
Study group	Role	What they receive
Experimental	Experimental	Interventional Combined Targeted Therapy、 Immunotherapy + Targeted Therapy、Immunotherapy + Targeted Therapy + Chemotherapy Receives: Procedure: Interventional; Drug: Targeted Therapy (anti-VEGF); Drug: Immunotherapy + Targeted Therapy; Drug: Immunotherapy + Targeted Therapy + Chemotherapy; Other: This cycle is repeated every 21 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival（PFS）
The time from treatment initiation to disease progression or death from any cause in cancer patients.
Measured: Approximately 1 day after disease progression or death from any cause in cancer patients.

Secondary outcomes (5)

Objective Response Rate（ORR）
The proportion of subjects who achieve complete response (CR) and partial response (PR) among the total subjects.
Measured: Approximately 1 month after imaging examination
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).
Measured: Approximately 1 month after imaging examination
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.
Measured: 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)
The time from initial treatment to death from any cause
Measured: Approximately 2 years after last participant enrollment.
Adverse Event (AE)
Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event.
Measured: Approximately 2 month after any treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202630 Nov 2028

First posted12 Jan 2026
Study start1 Feb 2026 (estimated)
Primary completion28 Feb 2027 (estimated)
Study completion30 Nov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pancreatic Cancer Liver MetastasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07333287
Sponsor's protocol ID: NO.2025-1074
Status last verified: Dec 2025
First submitted: 30 Dec 2025
Last updated: 12 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 39879814

Interested in taking part?

Dan Sha

+86 13573175130

shadan@sdfmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Pancreatic Cancer Liver Metastases trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT07333287
Acronym / sponsor ID: NO.2025-1074
Conditions: Pancreatic Cancer Liver Metastases, Immunotherapy-naive
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 38 participants (estimated)
Lead sponsor: Shandong Provincial HospitalOther government
Study start: 1 Feb 2026 (estimated)
Primary completion: 28 Feb 2027 (estimated)
Study completion: 30 Nov 2028 (estimated)
First posted: 12 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Procedure: Interventional, Drug: Targeted Therapy (anti-VEGF), Drug: Immunotherapy + Targeted Therapy, Drug: Immunotherapy + Targeted Therapy + Chemotherapy, Other: This cycle is repeated every 21 days.Interventional Combined Targeted Therapy、 Immunotherapy + Targeted Therapy、Immunotherapy + Targeted Therapy + Chemotherapy

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

1. Voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.
2. 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).
6. Must have measurable lesions according to RECIST 1.1 criteria. 7. No prior systemic therapy for pancreatic cancer or liver metastases, including chemotherapy, targeted therapy, or immunotherapy. (Note: Patients who received only one prior cycle of treatment, or oral targeted/chemotherapy agents for a cumulative duration ≤ 14 days, or those with recurrence more than six months after completing adjuvant chemotherapy may be considered for inclusion.) 8. Selective arterial catheterization and angiography demonstrate staining of pancreatic tumors and liver metastases. Patients with good tumor blood supply are eligible for this study.
9. 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.
10. Recovery from toxicities caused by prior therapies: ≥4 weeks since prior cytotoxic drugs, radiotherapy, or surgery, with wounds fully healed.

Key exclusion criteria (35 listed)

Subjects meeting any of the following criteria will be excluded from this study:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InterventionalPancreatic tumor and liver metastases: TAC Liver metastases: For non-diffuse liver metastases with good blood supply: TACE	Procedure or surgery	Experimental
Targeted Therapy (anti-VEGF)Apatinib 250 mg qd	Drug	Experimental
Immunotherapy + Targeted TherapyAfter 1-2 weeks Iparomlimab and Tuvonralimab (50 mg/2 mL) combined with Apatinib 250 mg qd	Drug	Experimental
Immunotherapy + Targeted Therapy + ChemotherapyAfter 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	Drug	Experimental
This cycle is repeated every 21 days.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.	Other	Experimental

Primary outcome

Progression-Free Survival（PFS）
Time frame: Approximately 1 day after disease progression or death from any cause in cancer patients.
The time from treatment initiation to disease progression or death from any cause in cancer patients.

5 secondary outcomes

Objective Response Rate（ORR）
Time frame: Approximately 1 month after imaging examination
Disease Control Rate（DCR）
Time frame: Approximately 1 month after imaging examination
Duration of Response（DOR）
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.
Overall Survival (OS)
Time frame: Approximately 2 years after last participant enrollment.
Adverse Event (AE)
Time frame: Approximately 2 month after any treatment

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
Results publication: PubMed 39879814Maekawa 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.
Individual participant dataSharing planned: Undecided

Related trials for Pancreatic Cancer Liver Metastases

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Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases
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RecruitingObservational study
Hepatic Artery Infusion Pump Chemotherapy for Liver Metastases From Resected Pancreatic and Duodenal Adenocarcinoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Dan Sha contact

+86 13573175130

shadan@sdfmu.edu.cn

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dan Sha (+86 13573175130, shadan@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival（PFS） (time frame: Approximately 1 day after disease progression or death from any cause in cancer patients.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07333287, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.