Intrahepatic Cholangiocarcinoma (Icc)Phase 2LPHAIC for ICCNCT07646717

Efficacy and Safety of HAIC Combined With Lenvatinib and PD-1 Inhibitors for Advanced Intrahepatic Cholangiocarcinoma

A Phase 2 study testing hepatic arterial infusion chemotherapy (Irinotecan liposome plus 5-FU/LV) combined with lenvatinib and PD-1 inhibitors in people with Intrahepatic Cholangiocarcinoma (Icc), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intrahepatic Cholangiocarcinoma (Icc)
What is being tested?: hepatic arterial infusion chemotherapy (Irinotecan liposome plus 5-FU/LV) combined with lenvatinib and PD-1 inhibitors
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 24 Feb 2026to 31 May 2028
Phase: Phase 2

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged between 18 and 80 years old.
Histologically or cytologically confirmed unresectable locally advanced or intrahepatic cholangiocarcinoma with metastasis.
Liver function: Child-Pugh Class A (score 5-6) or favorable Class B (score ≤7).
Have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Estimated survival time > 12 months.

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No prior systemic therapy for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma. Patients who received one line of adjuvant or neoadjuvant chemotherapy and experienced recurrence more than 6 months after chemotherapy completion are eligible.
Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L, hemoglobin ≥ 90 g/dL, Platelet (PLT) ≥ 100×10⁹/L, White Blood Cell (WBC) ≥ 3.0×10⁹/L.
Adequate renal function: Serum Creatinine (Cr) ≤ 1.5 × Upper Limit of Normal (ULN), or Creatinine Clearance (CCr) ≥ 60 mL/min (calculated by Cockcroft-Gault formula).
Adequate coagulation function: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 × ULN.
No active or suspected infection.
Female patients are not pregnant or breastfeeding. Fertile female and male patients must use effective contraception during the study and for 6 months after the end of study treatment.
Patients shall have good compliance, be able to understand the study procedures, and provide written informed consent.

Who cannot join

Patients with a history of other malignant tumors within the past 5 years, except for cured carcinoma in situ and basal cell carcinoma of the skin.
Patients with obvious clinical bleeding symptoms or bleeding tendency within 3 months prior to treatment, including bleeding volume > 30 mL, hematemesis, melena, hematochezia, or hemoptysis with fresh blood > 5 mL within 4 weeks.
Patients with a history of venous or arterial thromboembolic events within the preceding 6 months, such as cerebrovascular accidents (transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism.
Patients requiring long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day).
Patients with extensive distant metastases (e.g., peritoneal metastasis, multiple bone or brain metastases).
Patients who have used strong CYP3A4 inducers within 3 weeks before the first dose, or strong CYP3A4 inhibitors / strong UGT1A1 inhibitors within 3 weeks before the first dose.

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Patients who have undergone major organ surgery within 4 weeks prior to treatment (excluding needle biopsy, central venous catheterization, port catheter placement, biliary stenting for biliary obstruction relief, percutaneous transhepatic biliary drainage and cholecystostomy), or those with planned elective surgery.
Patients with active cardiac diseases within 6 months prior to treatment, including myocardial infarction and severe/unstable angina. Left ventricular ejection fraction < 50% on echocardiography, or uncontrolled arrhythmia.
Patients with congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (abnormal transaminases; HBV DNA ≥ 1000 IU/mL for hepatitis B, HCV RNA ≥ 1000 IU/mL for hepatitis C).
Chronic HBV carriers with HBV DNA < 2000 IU/mL are eligible only if they receive concomitant antiviral therapy throughout the study.
Patients with any other clinically significant metabolic, physical or laboratory abnormalities. At the investigator's discretion, patients with conditions unsuitable for the study drug (e.g., seizures requiring treatment), conditions that may interfere with interpretation of study results, or that place the patient at excessive risk are excluded.
Patients with intestinal obstruction (excluding incomplete intestinal obstruction managed solely with enteral nutrition), or patients at risk of intestinal perforation (including but not limited to acute diverticulitis, abdominal abscess, and history of abdominal malignancy).
Pregnant or breastfeeding female subjects.

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: Efficacy and Safety of First-line Hepatic Arterial Infusion Chemotherapy With Liposomal Irinotecan Plus 5-FU/LV Combined With Lenvatinib and PD-1 Inhibitors for Advanced Intrahepatic Cholangiocarcinoma

Intrahepatic Cholangiocarcinoma (ICC), the second most prevalent primary malignant liver neoplasm, features highly aggressive biological behavior and dismal prognosis. Even following curative surgical resection, patients have a 5-year overall survival rate lower than 5%, while unresectable patients achieve a median overall survival of only around 6 months. Most patients are diagnosed with locally advanced disease; frequently, surgical resection is contraindicated owing to unfavorable tumor location, vascular invasion or multifocal tumor spread. Therefore, exploring effective therapeutic strategies to boost survival outcomes for such patients is extremely critical.

China carries a heavy disease burden of biliary tract malignancies, with approximately 140,000 newly diagnosed cases each year. The incidence of cholangiocarcinoma exceeds 6 per 100,000 persons (more than 84,000 annual new cases). Moreover, intrahepatic cholangiocarcinoma outnumbers extrahepatic cholangiocarcinoma in incidence, which underscores the urgent demand for optimized treatment strategies.

Hepatic Arterial Infusion Chemotherapy (HAIC) is a regional therapeutic approach. Its theoretical foundation lies in the biological trait that malignant liver tumors are predominantly supplied by the hepatic artery. This modality delivers high-dose chemotherapeutic agents straight to tumor lesions through arterial routes, raising local intratumoral drug concentration and simultaneously reducing systemic adverse toxic reactions.

In recent years, innovations in interventional techniques - especially the application of modified percutaneous hepatic arterial chemotherapy port implantation - have greatly elevated the safety, feasibility and patient adherence of HAIC. Hence, HAIC has attracted extensive attention in treating hepatobiliary malignancies including ICC. Current research focuses on the value of HAIC monotherapy, HAIC combined with systemic chemotherapy, targeted therapy or immunotherapy for unresectable ICC, as well as its potential role as neoadjuvant therapy.

Conditions: Intrahepatic Cholangiocarcinoma (Icc)
Being tested: hepatic arterial infusion chemotherapy (Irinotecan liposome plus 5-FU/LV) combined with lenvatinib and PD-1 inhibitors
Keywords: Intrahepatic Cholangiocarcinoma, Hepatic Arterial Infusion Chemotherapy, HAIC, Irinotecan Liposome, Lenvatinib, Tislelizumab
Medical subject headings: Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension

What participants receive

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

hepatic arterial infusion chemotherapy (Irinotecan liposome plus 5-FU/LV) combined with lenvatinib and PD-1 inhibitorsDrug
Each treatment cycle lasts 21 days. Treatment response and tolerability will be evaluated after 2 cycles. The investigator will decide to discontinue treatment or continue for an additional 2-4 cycles accordingly.

Study groups in NCT07646717
Study group	Role	What they receive
HAIC (Irinotecan liposome plus 5-FU/LV ) combined with lenvatinib and Tislelizumab	Experimental	HAIC (Hepatic Arterial Infusion Chemotherapy) Irinotecan liposome: 70 mg/m², infused over 90 minutes on Day 1 Leucovorin (LV): 400 mg/m², infused over 2 hours on Day 1 5-Fluorouracil (5-FU): 2400 mg/m², infused over 24 hours on Day 1 Lenvatinib: 8 mg, orally once daily PD-1 inhibitor: 200 mg, infused over 30 minutes on Day 1 Receives: Drug: hepatic arterial infusion chemotherapy (Irinotecan liposome plus 5-FU/LV) combined with lenvatinib and PD-1 inhibitors

What is being measured

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

Objective Response Rate
Proportion of patients with CR or PR assessed by RECIST v1.1 and mRECIST
Measured: From enrollment to the end of treatment at 8-12 weeks

Secondary outcomes (5)

Disease Control Rate (DCR)
Proportion of patients with CR, PR or SD based on RECIST v1.1 and mRECIST
Measured: From enrollment to the end of treatment at 8-12 weeks
Adverse events (AEs)
AEs will be graded per NCI-CTCAE v5.0. Evaluate overall AE rate, grade-specific AE rate, Grade ≥3 AE rate and SAE rate.
Measured: From enrollment to the end of treatment, up to 6 months
Conversion Resection Rate
Rate of successful radical resection in patients with initially unresectable lesions post treatment
Measured: From enrollment to the end of treatment at 12-24 weeks
Progression-Free Survival (PFS)
Time from treatment start to disease progression (RECIST v1.1 and mRECIST)
Measured: Time from treatment start to disease progression, up to 6 months
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Measured: Time from treatment initiation to death from any cause, an average of 2 years.

Timeline

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

24 Feb 202631 May 2028

First posted15 Jun 2026
Study start24 Feb 2026
Primary completion31 Dec 2027 (estimated)
Study completion31 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intrahepatic Cholangiocarcinoma (Icc)Studies 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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07646717
Sponsor's protocol ID: E20260006
Acronym: LPHAIC for ICC
Status last verified: Jan 2026
First submitted: 9 Jun 2026
Last updated: 15 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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 locations

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