Intrahepatic Cholangiocarcinoma (Icc)Phase 2NCT07304388
HAIC Plus Systemic Chemotherapy, Lenvatinib and Toripalimab in Advanced ICC
A Phase 2 study testing hepatic arterial infusion chemotherapy (HAIC) and Chemotherapy in people with Intrahepatic Cholangiocarcinoma (Icc), run by Sun Yat-sen University at 1 site in China.
Trial summary
Prognosis for unresectable intrahepatic cholangiocarcinoma (ICC) remains poor. Treatment combination known as Gemox (systemic chemotherapy of gemcitabine and oxaliplatin), along with lenvatinib and toripalimab, has shown favor results for ICC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (Icc)
- What is being tested?
- hepatic arterial infusion chemotherapy (HAIC) and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2023to 1 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven ICC with locally advanced or metastatic disease deemed unresectable by multidisciplinary evaluation; At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors（RECIST v1.1）; Child-Pugh class A or B; ECOG performance status 0-1; Adequate bone marrow function（white blood cell count ≥2,000cells/mm3, hemoglobin > 9.0 g/dL, Platelet count ≥75,000/mm3）; Adequate hepatic and renal function (albumin ≥ 30 g/L, total bilirubin < 3 times the upper limit of normal, aspartate and alanine transaminases < 5 times the upper limit of normal, creatinine clearance rate of ≤ 1.5 times the upper limit of the normal) and coagulation function（PT < 18s, INR < 1.26）; written informed consent.
Who cannot join
- Life expectancy less than 2 months; concurrent other malignancy; Prior anticancer therapy (including chemotherapy, radiotherapy, surgery, or interventional treatments); Known allergy to chemotherapy drugs, lenvatinib or PD-(L)1 inhibitors; Patients with uncontrolled comorbidities, active infections; pregnancy or lactation; Refuse to comply with study and/or follow-up procedures; Gastrointestinal bleeding of any grade within 4 weeks prior to the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Chemotherapy, Lenvatinib and Toripalimab With or Without Hepatic Arterial Infusion In Advanced Intrahepatic Cholangiocarcinoma: A Prospective, Randomized, Two-Cohort, Phase II Study.
Prognosis for unresectable intrahepatic cholangiocarcinoma (ICC) remains poor. Treatment combination known as Gemox (systemic chemotherapy of gemcitabine and oxaliplatin), along with lenvatinib and toripalimab, has shown favor results for ICC patients. However, Hepatic Arterial Infusion Chemotherapy (HAIC), which delivers chemotherapy directly to the liver, has also demonstrated benefits in controlling the cancer locally and improving survival for patients with ICC.
Based on these promising approaches, this study aims to find out if adding HAIC to the systemic chemotherapy-based treatment can help extending patients survival.
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Being tested
- hepatic arterial infusion chemotherapy (HAIC), Chemotherapy
- Keywords
- HAIC, GemOx, combined therapy, lenvatinib, immunotherapy
- 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 (HAIC)Procedure or surgery
Hepatic arterial infusion chemotherapy:
oxaliplatin 85mg/m2 via HAIC pump for 3 hours on day 1; Q3W Drug: Gemcitabine
1g/m2 intravenously on day 1 and day 8 of a 3 weeks cycle Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing Drug: Toripalimab 240 mg iv.drip Q3W
ChemotherapyDrug
Systemic chemotherapy of GemOx regimen:
oxaliplatin 85mg/m2 and gemcitabine 1g/m2 intravenously on day 1, and gemcitabine 1g/m2 intravenously on day 8 of a 3 weeks cycle.
Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing Drug: Toripalimab 240 mg iv.drip Q3W
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: Hepatic arterial infusion plus systemic chemotherapy, lenvatinib and toripalimab | Experimental | Not described Receives: Procedure: hepatic arterial infusion chemotherapy (HAIC) |
| Control arm: Gemox plus lenvatinib and toripalimab | Active comparator | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-months PFS
6-months Progression-Free Survival Rate (6-months PFS rate) is defined as the proportion of patients who remain alive and free from disease progression (as assessed by RECIST v1.1) at 6 months from the initiation of study randomization.
Measured: 6 months
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.
Measured: 18 months
Overall Survival (OS)
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Measured: 18 months
Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Measured: 18 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v5.0
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start10 Feb 2023
- Primary completion1 Apr 2025
- Study completion1 Jun 2025
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 Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304388
- Sponsor's protocol ID
- IA3GM-II
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Chemotherapy, Lenvatinib and Toripalimab With or Without Hepatic Arterial Infusion In Advanced Intrahepatic Cholangiocarcinoma: A Prospective, Randomized, Two-Cohort, Phase II Study.
- ClinicalTrials.gov ID
- NCT07304388
- Acronym / sponsor ID
- IA3GM-II
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Keywords
- HAIC, GemOx, combined therapy, lenvatinib, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 26 Dec 2025 (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.
Prognosis for unresectable intrahepatic cholangiocarcinoma (ICC) remains poor. Treatment combination known as Gemox (systemic chemotherapy of gemcitabine and oxaliplatin), along with lenvatinib and toripalimab, has shown favor results for ICC patients. However, Hepatic Arterial Infusion Chemotherapy (HAIC), which delivers chemotherapy directly to the liver, has also demonstrated benefits in controlling the cancer locally and improving survival for patients with ICC.
Based on these promising approaches, this study aims to find out if adding HAIC to the systemic chemotherapy-based treatment can help extending patients survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: Hepatic arterial infusion plus systemic chemotherapy, lenvatinib and toripalimab | Experimental | Procedure: hepatic arterial infusion chemotherapy (HAIC) |
| Control arm: Gemox plus lenvatinib and toripalimab | Active comparator | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically proven ICC with locally advanced or metastatic disease deemed unresectable by multidisciplinary evaluation; At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors（RECIST v1.1）; Child-Pugh class A or B; ECOG performance status 0-1; Adequate bone marrow function（white blood cell count ≥2,000cells/mm3, hemoglobin > 9.0 g/dL, Platelet count ≥75,000/mm3）; Adequate hepatic and renal function (albumin ≥ 30 g/L, total bilirubin < 3 times the upper limit of normal, aspartate and alanine transaminases < 5 times the upper limit of normal, creatinine clearance rate of ≤ 1.5 times the upper limit of the normal) and coagulation function（PT < 18s, INR < 1.26）; written informed consent.
Key exclusion criteria (1 listed)
- Life expectancy less than 2 months; concurrent other malignancy; Prior anticancer therapy (including chemotherapy, radiotherapy, surgery, or interventional treatments); Known allergy to chemotherapy drugs, lenvatinib or PD-(L)1 inhibitors; Patients with uncontrolled comorbidities, active infections; pregnancy or lactation; Refuse to comply with study and/or follow-up procedures; Gastrointestinal bleeding of any grade within 4 weeks prior to the treatment.
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)Hepatic arterial infusion chemotherapy: oxaliplatin 85mg/m2 via HAIC pump for 3 hours on day 1; Q3W Drug: Gemcitabine 1g/m2 intravenously on day 1 and day 8 of a 3 weeks cycle Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing Drug: Toripalimab 240 mg iv.drip Q3W | Procedure or surgery | Experimental arm: Hepatic arterial infusion plus systemic chemotherapy, lenvatinib and toripalimab |
| ChemotherapySystemic chemotherapy of GemOx regimen: oxaliplatin 85mg/m2 and gemcitabine 1g/m2 intravenously on day 1, and gemcitabine 1g/m2 intravenously on day 8 of a 3 weeks cycle. Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing Drug: Toripalimab 240 mg iv.drip Q3W | Drug | Control arm: Gemox plus lenvatinib and toripalimab |
Primary outcome
6-months PFS
Time frame: 6 months
6-months Progression-Free Survival Rate (6-months PFS rate) is defined as the proportion of patients who remain alive and free from disease progression (as assessed by RECIST v1.1) at 6 months from the initiation of study randomization.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 18 months
Overall Survival (OS)
Time frame: 18 months
Progression Free Survival (PFS)
Time frame: 18 months
Adverse Events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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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 (HAIC) and Chemotherapy in people with Intrahepatic Cholangiocarcinoma (Icc), run by Sun Yat-sen University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
6-months PFS (time frame: 6 months). 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 30 Dec 2025.