Intrahepatic CholangiocarcinomaPhase 2NCT07432568
A Study of Liposomal Irinotecan Plus 5-FU/LV HAIC With Lenvatinib and a PD-1 Inhibitor in Advanced ICC
A Phase 2 study testing Hepatic Arterial Infusion Chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, Leucovorin, Lenvatinib and PD-1 Inhibitor in people with Intrahepatic Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a prospective, single-center, single-arm clinical study. It aims to evaluate the efficacy and safety of a new combination therapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC) who cannot be treated with surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Hepatic Arterial Infusion Chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, Leucovorin, Lenvatinib and PD-1 Inhibitor
- 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
- No sites listed yet
- Study dates
- 9 Mar 2026to 9 Aug 2032
- 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
- Aged 18 to 75 years.
- Histologically or cytologically confirmed unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (ICC).
- Liver function: Child-Pugh class A (score 5-6) or good class B (score ≤7).
- At least one measurable lesion as defined by RECIST 1.1 criteria.
- ECOG performance status of 0 or 1.
- Life expectancy greater than 12 months.
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- No prior systemic therapy for unresectable locally advanced or metastatic ICC. Prior adjuvant or neoadjuvant chemotherapy is allowed if completed >6 months before recurrence.
- Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L, Hemoglobin ≥90 g/L, Platelet count (PLT) ≥100×10⁹/L, White Blood Cell count (WBC) ≥3.0×10⁹/L.
- Adequate renal function: Serum creatinine (Cr) ≤1.5 × 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.
- Not pregnant or lactating. Female and male participants of childbearing potential must use effective contraception during the study and for 6 months after the last dose.
- Good compliance, ability to understand the study procedures, and provision of signed informed consent.
Who cannot join
- History of other malignancies within the past 5 years (except cured carcinoma in situ or basal cell skin cancer).
- Significant clinical bleeding symptoms or tendency within 3 months prior to treatment (e.g., >30 mL bleeding, hematemesis, melena, hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks). Venous/thrombotic events within the past 6 months (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism). Requirement for long-term anticoagulation (e.g., warfarin, heparin) or antiplatelet therapy (Aspirin ≥300 mg/day or Clopidogrel ≥75 mg/day).
- Extensive distant metastasis (e.g., peritoneal metastasis, multiple bone/brain metastases).
- Use of strong CYP3A4 inducers within 3 weeks prior to first dose, or use of strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 3 weeks prior to first dose.
- Major organ surgery within 4 weeks prior to treatment (excluding needle biopsy, central venous catheter placement, port implantation, biliary stenting, percutaneous transhepatic biliary drainage, cholecystostomy) or planned elective surgery.
- Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina. Left ventricular ejection fraction (LVEF) <50% by echocardiogram, or poorly controlled arrhythmia.
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- Congenital or acquired immunodeficiency (e.g., HIV infection), or active hepatitis (abnormal liver enzymes; for Hepatitis B: HBV DNA ≥1000 IU/mL; for Hepatitis C: HCV RNA ≥1000 IU/mL). Chronic HBV carriers with HBV DNA <2000 IU/ml can be enrolled if they receive concurrent antiviral therapy during the trial.
- Any other disease, metabolic disorder, physical examination finding, or laboratory abnormality that, in the investigator's judgment, contraindicates the use of the study drug, may affect result interpretation, or places the patient at high risk.
- Bowel obstruction (except incomplete obstruction manageable with enteral nutrition) or patients at risk of bowel perforation (e.g., acute diverticulitis, abdominal abscess, history of abdominal cancer).
- Pregnant or lactating female participants.
About this study
Official title: A Prospective Study on the Efficacy and Safety of Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Lenvatinib and a PD-1 Inhibitor as First-Line Therapy for Advanced Intrahepatic Cholangiocarcinoma (ICC)
This is a prospective, single-center, single-arm clinical study. It aims to evaluate the efficacy and safety of a new combination therapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC) who cannot be treated with surgery. The combined therapy includes hepatic arterial infusion chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin, along with the oral targeted drug Lenvatinib and an intravenous PD-1 inhibitor (an immunotherapy). A total of 30 participants will be enrolled. The main goal of the study is to measure the Objective Response Rate (ORR), which is the percentage of patients whose cancer shrinks or disappears after treatment.
Read the detailed description
This study investigates a novel therapeutic strategy for unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (ICC). Despite being the second most common primary liver malignancy, advanced ICC has a poor prognosis with limited effective first-line treatment options. The rationale for this combination regimen is based on the potential synergy between localized and systemic therapies. Hepatic arterial infusion chemotherapy delivers high concentrations of chemotherapy directly to the liver tumors, potentially improving local control while reducing systemic toxicity. The combination of Lenvatinib, a multi-targeted tyrosine kinase inhibitor, and a PD-1 inhibitor is designed to simultaneously inhibit tumor angiogenesis and enhance anti-tumor immunity. This study will explore whether combining these modalities (HAIC + targeted therapy + immunotherapy) can yield superior efficacy compared to historical data of standard chemotherapy. The liposomal formulation of irinotecan is utilized for its improved pharmacokinetic profile and targeted delivery, which may enhance efficacy and tolerability. Key assessments include tumor evaluation based on RECIST 1.1 criteria and safety monitoring per NCI CTCAE v5.0.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Hepatic Arterial Infusion Chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, Leucovorin, Lenvatinib, PD-1 Inhibitor
- Keywords
- Hepatic Arterial Infusion Chemotherapy(HAIC), Liposomal Irinotecan, 5-Fluorouracil, Leucovorin, Lenvatinib, PD-1 Inhibitor, Immunotherapy, Targeted Therapy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic Arterial Infusion Chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, LeucovorinOther
Liposomal Irinotecan (70 mg/m²) infused over 90 minutes, followed by Leucovorin (400 mg/m²) infused over 2 hours, and then 5-Fluorouracil (2400 mg/m²) infused over 24 hours via hepatic arterial infusion on Day 1 of each 21-day cycle. The number of treatment cycles (2 to 6) is determined by the investigator based on tumor response and tolerability after the initial 2 cycles.
LenvatinibDrug
Lenvatinib is administered orally at a dose of 8 mg once daily, continuously throughout each 21-day cycle.
PD-1 InhibitorDrug
A PD-1 inhibitor (specific agent chosen at the investigator's discretion) is administered via intravenous infusion on Day 1 of each 21-day cycle, approximately 24 hours prior to the initiation of HAIC.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Group | Experimental | All participants receive the combined regimen of hepatic arterial infusion chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin, plus oral Lenvatinib and an intravenous PD-1 inhibitor as first-line treatment. Receives: Other: Hepatic Arterial Infusion Chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, Leucovorin; Drug: Lenvatinib; Drug: PD-1 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Every 2 cycles (each cycle is 21 days ) during the treatment period
Secondary outcomes (4)
Progression-Free Survival (PFS)
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall Survival (OS)
Measured: From date of first dose until the date of death from any cause, assessed up to 60 months
Disease Control Rate (DCR)
Measured: From date of first dose until the date of first documented progression or the end of treatment, whichever came first, assessed up to 24 months
Conversion Resection Rate
Measured: From date of first dose until the date of radical surgery, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start9 Mar 2026 (estimated)
- Primary completion9 Jun 2032 (estimated)
- Study completion9 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies 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 (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432568
- Sponsor's protocol ID
- CSPC-DNY-BTC-TJ03
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes. De-identified individual participant data that underlie the results reported in the primary publication (including data dictionaries) will be made available upon reasonable request to qualified researchers. Proposals should be directed to 210412103@sust.edu.cn. Data will be available beginning 12 months after article publication, with no end date. Requestors will need to sign a data access agreement and obtain approval from an institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Efficacy and Safety of Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Lenvatinib and a PD-1 Inhibitor as First-Line Therapy for Advanced Intrahepatic Cholangiocarcinoma (ICC)
- ClinicalTrials.gov ID
- NCT07432568
- Acronym / sponsor ID
- CSPC-DNY-BTC-TJ03
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Hepatic Arterial Infusion Chemotherapy(HAIC), Liposomal Irinotecan, 5-Fluorouracil, Leucovorin, Lenvatinib, PD-1 Inhibitor, Immunotherapy, Targeted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- 9 Jun 2032 (estimated)
- Study completion
- 9 Aug 2032 (estimated)
- First posted
- 25 Feb 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.
This is a prospective, single-center, single-arm clinical study. It aims to evaluate the efficacy and safety of a new combination therapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC) who cannot be treated with surgery. The combined therapy includes hepatic arterial infusion chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin, along with the oral targeted drug Lenvatinib and an intravenous PD-1 inhibitor (an immunotherapy). A total of 30 participants will be enrolled. The main goal of the study is to measure the Objective Response Rate (ORR), which is the percentage of patients whose cancer shrinks or disappears after treatment.
Detailed description
This study investigates a novel therapeutic strategy for unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (ICC). Despite being the second most common primary liver malignancy, advanced ICC has a poor prognosis with limited effective first-line treatment options. The rationale for this combination regimen is based on the potential synergy between localized and systemic therapies. Hepatic arterial infusion chemotherapy delivers high concentrations of chemotherapy directly to the liver tumors, potentially improving local control while reducing systemic toxicity. The combination of Lenvatinib, a multi-targeted tyrosine kinase inhibitor, and a PD-1 inhibitor is designed to simultaneously inhibit tumor angiogenesis and enhance anti-tumor immunity. This study will explore whether combining these modalities (HAIC + targeted therapy + immunotherapy) can yield superior efficacy compared to historical data of standard chemotherapy. The liposomal formulation of irinotecan is utilized for its improved pharmacokinetic profile and targeted delivery, which may enhance efficacy and tolerability. Key assessments include tumor evaluation based on RECIST 1.1 criteria and safety monitoring per NCI CTCAE v5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Experimental | Other: Hepatic Arterial Infusion Chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, Leucovorin, Drug: Lenvatinib, Drug: PD-1 InhibitorAll participants receive the combined regimen of hepatic arterial infusion chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin, plus oral Lenvatinib and an intravenous PD-1 inhibitor as first-line treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18 to 75 years.
- Histologically or cytologically confirmed unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (ICC).
- Liver function: Child-Pugh class A (score 5-6) or good class B (score ≤7).
- At least one measurable lesion as defined by RECIST 1.1 criteria.
- ECOG performance status of 0 or 1.
Key exclusion criteria (10 listed)
- History of other malignancies within the past 5 years (except cured carcinoma in situ or basal cell skin cancer).
- Significant clinical bleeding symptoms or tendency within 3 months prior to treatment (e.g., >30 mL bleeding, hematemesis, melena, hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks). Venous/thrombotic events within the past 6 months (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism). Requirement for long-term anticoagulation (e.g., warfarin, heparin) or antiplatelet therapy (Aspirin ≥300 mg/day or Clopidogrel ≥75 mg/day).
- Extensive distant metastasis (e.g., peritoneal metastasis, multiple bone/brain metastases).
- Use of strong CYP3A4 inducers within 3 weeks prior to first dose, or use of strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 3 weeks prior to first dose.
- Major organ surgery within 4 weeks prior to treatment (excluding needle biopsy, central venous catheter placement, port implantation, biliary stenting, percutaneous transhepatic biliary drainage, cholecystostomy) or planned elective surgery.
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 (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, LeucovorinLiposomal Irinotecan (70 mg/m²) infused over 90 minutes, followed by Leucovorin (400 mg/m²) infused over 2 hours, and then 5-Fluorouracil (2400 mg/m²) infused over 24 hours via hepatic arterial infusion on Day 1 of each 21-day cycle. The number of treatment cycles (2 to 6) is determined by the investigator based on tumor response and tolerability after the initial 2 cycles. | Other | Combination Therapy Group |
| LenvatinibLenvatinib is administered orally at a dose of 8 mg once daily, continuously throughout each 21-day cycle. | Drug | Combination Therapy Group |
| PD-1 InhibitorA PD-1 inhibitor (specific agent chosen at the investigator's discretion) is administered via intravenous infusion on Day 1 of each 21-day cycle, approximately 24 hours prior to the initiation of HAIC. | Drug | Combination Therapy Group |
Primary outcome
Objective Response Rate (ORR)
Time frame: Every 2 cycles (each cycle is 21 days ) during the treatment period
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall Survival (OS)
Time frame: From date of first dose until the date of death from any cause, assessed up to 60 months
Disease Control Rate (DCR)
Time frame: From date of first dose until the date of first documented progression or the end of treatment, whichever came first, assessed up to 24 months
Conversion Resection Rate
Time frame: From date of first dose until the date of radical surgery, assessed up to 24 months
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 25 Feb 2026.
- Individual participant dataSharing planned: Yes. Yes. De-identified individual participant data that underlie the results reported in the primary publication (including data dictionaries) will be made available upon reasonable request to qualified researchers. Proposals should be directed to 210412103@sust.edu.cn. Data will be available beginning 12 months after article publication, with no end date. Requestors will need to sign a data access agreement and obtain approval from an institutional review board.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hepatic Arterial Infusion Chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, Leucovorin, Lenvatinib and PD-1 Inhibitor in people with Intrahepatic Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
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 10 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 25 Feb 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?
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 (ORR) (time frame: Every 2 cycles (each cycle is 21 days ) during the treatment period). 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 25 Feb 2026.