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.
Trial summary
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… Read more about this study
- 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
- 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 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
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.
Read more
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 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.
- 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.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07646717
- Acronym / sponsor ID
- LPHAIC for ICC / E20260006
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Keywords
- Intrahepatic Cholangiocarcinoma, Hepatic Arterial Infusion Chemotherapy, HAIC, Irinotecan Liposome, Lenvatinib, Tislelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 15 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC (Irinotecan liposome plus 5-FU/LV ) combined with lenvatinib and Tislelizumab | Experimental | Drug: hepatic arterial infusion chemotherapy (Irinotecan liposome plus 5-FU/LV) combined with lenvatinib and PD-1 inhibitorsHAIC (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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
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 |
|---|---|---|
| hepatic arterial infusion chemotherapy (Irinotecan liposome plus 5-FU/LV) combined with lenvatinib and PD-1 inhibitorsEach 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. | Drug | HAIC (Irinotecan liposome plus 5-FU/LV ) combined with lenvatinib and Tislelizumab |
Primary outcome
Objective Response Rate
Time frame: From enrollment to the end of treatment at 8-12 weeks
Proportion of patients with CR or PR assessed by RECIST v1.1 and mRECIST
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: From enrollment to the end of treatment at 8-12 weeks
Adverse events (AEs)
Time frame: From enrollment to the end of treatment, up to 6 months
Conversion Resection Rate
Time frame: From enrollment to the end of treatment at 12-24 weeks
Progression-Free Survival (PFS)
Time frame: Time from treatment start to disease progression, up to 6 months
Overall Survival (OS)
Time frame: Time from treatment initiation to death from any cause, an average of 2 years.
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 15 Jun 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 13 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From enrollment to the end of treatment at 8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.