HCCNCT07340502
TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma
An observational study of HCC, run by Tongji Hospital.
Trial summary
Although the combination of transarterial chemoembolization (TACE) with PD-1 inhibitor plus lenvatinib has become a new standard, the therapeutic efficacy for unresectable hepatocellular carcinoma (uHCC) still requires improvement, as TACE remains limited for patients with multifocal lesions, hypovascular tumors, or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- TACE, HAIC and PD-1inhibitors
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 31 Dec 2028
- Phase
- Observational
- 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
Study population: This is a multicenter, prospective, observational cohort study designed to evaluate the efficacy and safety, primarily in terms of progression-free survival (PFS), of transarterial chemoembolization (TACE) versus hepatic arterial infusion chemotherapy (HAIC), each combined with a PD-1 inhibitor and lenvatinib, in the treatment of unresectable hepatocellular carcinoma (HCC). The study plans to enroll a total of 364 patients, who will be prospectively followed for treatment efficacy and adverse events. The primary endpoint is PFS. Secondary endpoints include the objective response rate (ORR), overall survival (OS), and safety.
Who may be able to join
- Aged between 18 and 75 years;
- Tumor stage classified as BCLC-A to -C, with no evidence of extrahepatic metastasis;
- Newly diagnosed, treatment-naïve hepatocellular carcinoma with no prior anticancer therapy;
- Child-Pugh liver function score ≤ 7;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1;
- Absence of severe organic diseases affecting major organs (e.g., heart, lung, brain).
Who cannot join
- Decompensated liver cirrhosis;
- Concurrent other malignancies or recurrent hepatocellular carcinoma;
- Any active, known, or suspected autoimmune disease;
- History of hypersensitivity to any component of PD-1 inhibitors or lenvatinib;
- Human immunodeficiency virus (HIV) infection; or active viral hepatitis (e.g., hepatitis B or C);
- Tumor thrombus involving the inferior vena cava, hepatic veins, or the main portal vein trunk.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective, Observational Cohort Study
Although the combination of transarterial chemoembolization (TACE) with PD-1 inhibitor plus lenvatinib has become a new standard, the therapeutic efficacy for unresectable hepatocellular carcinoma (uHCC) still requires improvement, as TACE remains limited for patients with multifocal lesions, hypovascular tumors, or those complicated with portal vein tumor thrombosis (PVTT). Hepatic arterial infusion chemotherapy (HAIC), as an alternative locoregional therapy, has demonstrated advantages in treating these refractory cases. Therefore, this study innovatively designs a prospective cohort study to conduct a comparison of the two triple-combination regimens-"HAIC plus PD-1 inhibitor and lenvatinib" versus "TACE plus PD-1 inhibitor and lenvatinib"-in terms of real-world efficacy and safety, with a focus on enrolling patients who are likely to have suboptimal responses to TACE. This research aims to provide high-level evidence for selecting the optimal combined locoregional strategy for uHCC patients, thereby directly guiding clinical practice and potentially advancing the optimization of treatment strategies and personalized precision medicine to improve patient survival outcomes.
Read the detailed description
This is a multicenter, prospective, observational cohort study designed to compare the efficacy and safety of transarterial chemoembolization (TACE) versus hepatic arterial infusion chemotherapy (HAIC), each combined with a programmed cell death protein-1 (PD-1) inhibitor and lenvatinib, for the treatment of unresectable hepatocellular carcinoma (uHCC), with a primary focus on progression-free survival (PFS). A total of 364 patients are planned to be enrolled and prospectively followed for efficacy and adverse events. The primary endpoint is PFS. Secondary endpoints include the objective response rate (ORR), overall survival (OS), and safety. Tumor response will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1). Assessments will be performed every 56 days (with a ±3-day window) from the initiation of study treatment until disease progression, patient death, withdrawal of consent, loss to follow-up, or study termination (whichever occurs first). For patients who experience disease progression or initiate other antitumor therapies, survival follow-up will be conducted every 8 weeks (56 days, with a ±7-day window) from the time the event is documented to collect information on subsequent antitumor treatments and survival status until death, withdrawal of consent, loss to follow-up, or study termination.
- Conditions
- HCC
- Being tested
- TACE, HAIC, PD-1inhibitors, Lenvatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
TACE blocks the tumor's blood supply while delivering high concentrations of chemotherapy agents directly into the hepatic artery. Patients received on-demand TACE until the end of the study or tumor progression.
HAICProcedure or surgery
HAIC involves the continuous infusion of high-dose chemotherapy into the hepatic artery via an indwelling catheter, enabling prolonged and deep tumor exposure. Patients received on-demand HAIC until the end of the study or tumor progression.
PD-1inhibitorsDrug
200mg was given intravenously every three weeks.
LenvatinibDrug
The dose is determined by body weight, body weight greater than or equal to 60kg, 12mg, oral; Less than 60kg, 8mg, orally.
| Study group | Role | What they receive |
|---|---|---|
| TACE-based combination treatment cohort | Patients in this group were treated with TACE plus a PD-1 inhibitor and lenvatinib Receives: Procedure: TACE; Drug: PD-1inhibitors; Drug: Lenvatinib | |
| HAIC-based combination treatment cohort | Patients in this group were treated with HAIC plus a PD-1 inhibitor and lenvatinib Receives: Procedure: HAIC; Drug: PD-1inhibitors; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS was defined as the time from enrollment to tumor progression.
Measured: From the date of enrollment, until the tumor progresses, the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 months.
Secondary outcomes (2)
Overall survival(OS)
OS was defined as the time from enrollment to death.
Measured: From date of enrollment until the date of death from any cause, assessed up to 96 months.
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a best response of either complete response (CR) or partial response (PR) during a specified treatment period.
Measured: From the date of enrollment, until the tumor progresses, the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Guang Zhang, Tongji Hospital
- Investigators
- Wanguang Zhang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340502
- Sponsor's protocol ID
- CHALLENGE-06
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07340502
- Acronym / sponsor ID
- CHALLENGE-06
- Conditions
- HCC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Jan 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.
Although the combination of transarterial chemoembolization (TACE) with PD-1 inhibitor plus lenvatinib has become a new standard, the therapeutic efficacy for unresectable hepatocellular carcinoma (uHCC) still requires improvement, as TACE remains limited for patients with multifocal lesions, hypovascular tumors, or those complicated with portal vein tumor thrombosis (PVTT). Hepatic arterial infusion chemotherapy (HAIC), as an alternative locoregional therapy, has demonstrated advantages in treating these refractory cases. Therefore, this study innovatively designs a prospective cohort study to conduct a comparison of the two triple-combination regimens-"HAIC plus PD-1 inhibitor and lenvatinib" versus "TACE plus PD-1 inhibitor and lenvatinib"-in terms of real-world efficacy and safety, with a focus on enrolling patients who are likely to have suboptimal responses to TACE. This research aims to provide high-level evidence for selecting the optimal combined locoregional strategy for uHCC patients, thereby directly guiding clinical practice and potentially advancing the optimization of treatment strategies and personalized precision medicine to improve patient survival outcomes.
Detailed description
This is a multicenter, prospective, observational cohort study designed to compare the efficacy and safety of transarterial chemoembolization (TACE) versus hepatic arterial infusion chemotherapy (HAIC), each combined with a programmed cell death protein-1 (PD-1) inhibitor and lenvatinib, for the treatment of unresectable hepatocellular carcinoma (uHCC), with a primary focus on progression-free survival (PFS). A total of 364 patients are planned to be enrolled and prospectively followed for efficacy and adverse events. The primary endpoint is PFS. Secondary endpoints include the objective response rate (ORR), overall survival (OS), and safety. Tumor response will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1). Assessments will be performed every 56 days (with a ±3-day window) from the initiation of study treatment until disease progression, patient death, withdrawal of consent, loss to follow-up, or study termination (whichever occurs first). For patients who experience disease progression or initiate other antitumor therapies, survival follow-up will be conducted every 8 weeks (56 days, with a ±7-day window) from the time the event is documented to collect information on subsequent antitumor treatments and survival status until death, withdrawal of consent, loss to follow-up, or study termination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE-based combination treatment cohort | – | Procedure: TACE, Drug: PD-1inhibitors, Drug: LenvatinibPatients in this group were treated with TACE plus a PD-1 inhibitor and lenvatinib |
| HAIC-based combination treatment cohort | – | Procedure: HAIC, Drug: PD-1inhibitors, Drug: LenvatinibPatients in this group were treated with HAIC plus a PD-1 inhibitor and lenvatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multicenter, prospective, observational cohort study designed to evaluate the efficacy and safety, primarily in terms of progression-free survival (PFS), of transarterial chemoembolization (TACE) versus hepatic arterial infusion chemotherapy (HAIC), each combined with a PD-1 inhibitor and lenvatinib, in the treatment of unresectable hepatocellular carcinoma (HCC). The study plans to enroll a total of 364 patients, who will be prospectively followed for treatment efficacy and adverse events. The primary endpoint is PFS. Secondary endpoints include the objective response rate (ORR), overall survival (OS), and safety.
Key inclusion criteria (6 listed)
- Aged between 18 and 75 years;
- Tumor stage classified as BCLC-A to -C, with no evidence of extrahepatic metastasis;
- Newly diagnosed, treatment-naïve hepatocellular carcinoma with no prior anticancer therapy;
- Child-Pugh liver function score ≤ 7;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1;
Key exclusion criteria (6 listed)
- Decompensated liver cirrhosis;
- Concurrent other malignancies or recurrent hepatocellular carcinoma;
- Any active, known, or suspected autoimmune disease;
- History of hypersensitivity to any component of PD-1 inhibitors or lenvatinib;
- Human immunodeficiency virus (HIV) infection; or active viral hepatitis (e.g., hepatitis B or C);
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 |
|---|---|---|
| TACETACE blocks the tumor's blood supply while delivering high concentrations of chemotherapy agents directly into the hepatic artery. Patients received on-demand TACE until the end of the study or tumor progression. | Procedure or surgery | TACE-based combination treatment cohort |
| HAICHAIC involves the continuous infusion of high-dose chemotherapy into the hepatic artery via an indwelling catheter, enabling prolonged and deep tumor exposure. Patients received on-demand HAIC until the end of the study or tumor progression. | Procedure or surgery | HAIC-based combination treatment cohort |
| PD-1inhibitors200mg was given intravenously every three weeks. | Drug | HAIC-based combination treatment cohort, TACE-based combination treatment cohort |
| LenvatinibThe dose is determined by body weight, body weight greater than or equal to 60kg, 12mg, oral; Less than 60kg, 8mg, orally. | Drug | HAIC-based combination treatment cohort, TACE-based combination treatment cohort |
Primary outcome
Progression-free survival (PFS)
Time frame: From the date of enrollment, until the tumor progresses, the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 months.
PFS was defined as the time from enrollment to tumor progression.
2 secondary outcomes
Overall survival(OS)
Time frame: From date of enrollment until the date of death from any cause, assessed up to 96 months.
Objective Response Rate (ORR)
Time frame: From the date of enrollment, until the tumor progresses, the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 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 14 Jan 2026.
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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.
Wanguang Zhang principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of HCC, run by Tongji 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 6 inclusion and 6 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 14 Jan 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.
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?
Contact Wanguang Zhang (13886195965, wgzhang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From the date of enrollment, until the tumor progresses, the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 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 14 Jan 2026.