Intrahepatic Cholangiocarcinoma (Icc)Phase 2HAIC-quadNCT06859684
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)
A Phase 2 study testing Durvalumab, hepatic arterial infusion chemotherapy (HAIC) and Lenvatinib in people with Intrahepatic Cholangiocarcinoma (Icc) and HAIC, run by West China Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (Icc), HAIC, Durvalumab
- What is being tested?
- Durvalumab, hepatic arterial infusion chemotherapy (HAIC) and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 6 Mar 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who have received systemic treatment in the past.
- Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
- Patients with severe and uncorrectable coagulation dysfunction.
- Patients with active hepatitis or severe infection who cannot be treated simultaneously.
- Patients with cachexia or multiple organ failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
yun X Zhang, PHD, +86-18011410585, zhangxiaoyun@wchscu.cn
About this study
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.
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc), HAIC, Durvalumab
- Being tested
- Durvalumab, hepatic arterial infusion chemotherapy (HAIC), Lenvatinib
- Keywords
- locally advanced or metastatic intrahepatic cholangiocarcinoma, durvalumab, Lenvatinib, HAIC
- 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.
DurvalumabDrug
Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W
hepatic arterial infusion chemotherapy (HAIC)Drug
hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was adopted, with the specific regimen as follows: cisplatin 60 mg/m2 on the first day, arterial infusion for half an hour, gemcitabine 1000 mg/m2 on the first day, arterial infusion for half an hour, repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles was determined by the investigator according to the patient's condition).
LenvatinibDrug
Lenvatinib 8mg (weight <60 kg) or 12mg (weight ≥60 kg) oral QD, during combination therapy, starting on day 3 of each 3-week cycle (determined by the investigator)
| Study group | Role | What they receive |
|---|---|---|
| HAIC-quad Arm | Experimental | Not described Receives: Drug: Durvalumab; Drug: hepatic arterial infusion chemotherapy (HAIC); Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
Measured: Up to approximately 26 months
Secondary outcomes (3)
Overall Survival (OS)
Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Measured: Up to approximately 36 months
Progression-free Survival (PFS)
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Measured: Up to approximately 26 months
Number of Participants Who Experience One or More Adverse Events (AE)
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025
- Primary completion6 Sep 2026 (estimated)
- Study completion6 Mar 2027 (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 West China 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Tianfu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859684
- Sponsor's protocol ID
- HAIC-quad-01
- Acronym
- HAIC-quad
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided