NCT06859684RecruitingPhase 2
Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
At present, the first-line treatment for patients with advanced unresectable intrahepatic cholangiocarcinoma is mainly systemic treatment, but the improvement in efficacy is limited and is not enough to meet the current clinical treatment needs. Hepatic artery infusion chemotherapy (HAIC) has the advantages of increasing local drug concentration and reducing toxic side effects compared to systemic intravenous chemotherapy. In order to enable patients with advanced intrahepatic cholangiocarcinoma to obtain better treatment effects, this study plans to explore HAIC combined with durvalumab and lenvatinib as the first-line treatment for patients with locally advanced or metastatic ICC, in order to provide a better treatment choice for their comprehensive treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 27 Feb 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 6 Sept 2026
- Lead sponsor
- West China Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06859684
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 1 Mar 2025 to the primary completion date, 6 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received systemic treatment in the past.
Other illness
- Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
- Patients with active hepatitis or severe infection who cannot be treated simultaneously.
- Patients with cachexia or multiple organ failure.
Other
- Patients with severe and uncorrectable coagulation dysfunction.
Who the study is looking for
- Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminary diagnosis of unresectable or metastatic disease and no previous systemic treatment.
- Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein or main bile duct, who cannot undergo resection and reconstruction; ② Patients with decompensated cirrhosis or severe portal hypertension, and the residual liver FLR does not meet the safe liver resection decision-making system Biological factors: ① Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodes such as the para-aorta or distant organ metastasis
- Disease recurrence \> 6 months after radical surgery; if adjuvant therapy is given after surgery, patients \> 6 months after completion of adjuvant therapy (chemotherapy and/or radiotherapy) are eligible for inclusion.
- WHO/ECOG PS of 0 or 1
- There was at least 1 target lesion (TL) that met the RECIST 1.1 criteria
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.