Efficacy and Safety of HAIC Combined With Lenvatinib and PD-1 Inhibitors for Advanced Intrahepati… (NCT07646717) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy and Safety of HAIC Combined With Lenvatinib and PD-1 Inhibitors for Advanced Intrahepatic Cholangiocarcinoma
China30 participantsStarted 2026-02-24
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a combination of three treatments — HAIC (hepatic arterial infusion chemotherapy), lenvatinib, and a PD-1 inhibitor — all at once for advanced intrahepatic cholangiocarcinoma; given that it's a Phase 2 study, what is currently known about the safety profile of this combination, and what side effects should I be most prepared for?
2Since this trial is no longer actively recruiting, is there any way for me to access this treatment combination outside of the trial, or are there similar studies still enrolling that might be worth looking into?
3The trial's main goal is to measure objective response rate, meaning how many patients' tumors shrink — how does that compare to what standard first-line treatments like gemcitabine plus cisplatin or the TOPAZ-1 regimen might achieve for someone in my situation?
4HAIC involves delivering chemotherapy directly into the hepatic artery, which is more invasive than standard intravenous chemotherapy — given my current liver function and overall health, is that kind of procedure something my care team would consider appropriate for me?
5Because this is a Phase 2 trial focused on response rates rather than long-term survival, what would the next steps look like if I responded well — or didn't respond — to this combination, and how might participating or not participating affect my future treatment options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: From enrollment to the end of treatment at 8-12 weeks
Trial details
NCT IDNCT07646717
SponsorTianjin Medical University Cancer Institute and Hospital