Liver CancerPhase 2FRONT-1NCT05532319
HAIC Sequential TAE Combined With Lenvatinib and Tislelizumab in Unresectable HCC
A Phase 2 study testing HAIC sequential TAE combined with lenvatinib and tislelizumab in people with Liver Cancer, run by Guangxi Medical University at 1 site in China.
Trial summary
Patients with unresectable hepatocellular carcinoma will receive hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- HAIC sequential TAE combined with lenvatinib and tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2022to 23 Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCC is diagnosed in accordance with the clinical diagnostic criteria of the Guidelines for the Diagnosis and Treatment of primary liver Cancer (2019 edition) issued by the Health Commission of the People's Republic of China or by histopathology;
- ECOG PS 0 or 1;
- Child-Pugh A liver function;
- Chinese Liver Cancer (CNLC) stage IIb, IIIa and IIIb patients, or CNLC stage Ib and IIA patients who cannot undergo hepatectomy for various reasons;
- Expected survival time ≥6 months;
- HCC patients with incomplete portal vein obstruction or complete portal vein obstruction with abundant compensatory collateral vessels;
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- Hematological indicators should meet the following conditions: hemoglobin ≥90 g/L; absolute neutrophil count ≥1.5×10^9/L; platelets ≥80×10^9/L; total bilirubin ≤1.5×ULN; ALT 3 x ULN or less; AST 3 x ULN or less; alkaline phosphatase ≤2.5×ULN; serum albumin ≥28 g/L; serum creatinine ≤1.5×ULN;
- Urinary protein <2+ or 24 h urinary protein < 1.0 g;
- For women of reproductive age, use of contraception (e.g. intrauterine devices, tablets or condoms) is required during the course of the clinical trial until 120 days after the end of the clinical trial; Women of childbearing age had negative serum or urine HCG test results within 7 days before enrollment in the study; male patients with potential reproductive partners should use effective contraception during the study period and for 120 days after the study.
Who cannot join
- Previous or co-existing other malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Previously received HAIC, TACE, TAE, radiofrequency ablation and other local treatments for HCC;
- Patients who have received or are using one of the following three drugs in the previous 6 months: ① immune checkpoint inhibitors, including but not limited to artemizumab, nivolumab, pembrolizumab, camrelizumab, sintilimab, toripalimab, and tislelizumab; ② molecular targeted therapy, including but not limited to sorafenib, lenvatinib, apatinib, regorafenib, anlotinib, bevacizumab, etc. ③ systemic chemotherapy drugs (such as doxorubicin, oxaliplatin, 5-FU, S-1, etc.);
- Having a congenital or acquired immunodeficiency disease (e.g. being HIV positive);
- Active infection, or body temperature ≥ 38.5℃ or white blood cell count > 15 x 10^9/L 7 days before enrollment;
- Within 3 months of enrollment, patients with hemorrhagic diseases (including but not limited to moderate/severe esophageal and gastric variceal bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, hemoptysis > 2.5 mL per day; For positive cases of fecal occult blood, occult blood should be reexamined, and gastroenteroscopy should be performed if necessary);
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- Arterial or venous thrombosis within 6 months, such as cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis, pulmonary infarction, etc.;
- Those who have a history of alcohol or psychotropic drug abuse and are unable to abstain or have mental disorders;
- Pregnant or lactating women;
- Active autoimmune diseases or previous autoimmune diseases (such as autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, etc.);
- Being treated with immunosuppressive agents or glucocorticoids (>10mg prednisone/day) within 2 weeks;
- Complicated with hepatic encephalopathy or brain metastasis;
- Medically uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) (based on the average of BP readings obtained from ≥2 measurements);
- Uncontrolled heart disease or symptoms (including but not limited to cardiac function grade II or above, unstable angina pectoris, myocardial infarction in the previous 1 year, supraventricular or ventricular arrhythmias requiring treatment or intervention);
- Abnormal coagulation (INR > 2.0, PT > 16 s), bleeding tendency or need for thrombolytic therapy or anticoagulant therapy (although prophylactic use of low-dose aspirin or low molecular weight heparin is permitted);
- Hereditary or acquired blood diseases (e.g. hemophilia, thrombocytopenia, coagulopathy, etc.);
- Urinary protein ≥ ++ and 24-hour urinary protein 1.0 g in urine routine;
- Patients with bone metastases requiring surgical treatment for bone metastases;
- Known hypersensitivity to active ingredients or excipients contained in the study drugs (tislelizumab, lenvatinib), or a history of severe allergy to any other monoclonal antibody or antiangiogenic targeted drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Hepatic Arterial inFusion Chemotherapy Sequential transaRterial Embolization cOmbined With leNvatinib and Tislelizumab in Unresectable Hepatocellular Carcinoma (FRONT Trial)
Patients with unresectable hepatocellular carcinoma will receive hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab.
Read the detailed description
In recent years, more and more studies have found that the efficacy of hepatic arterial infusion chemotherapy (HAIC) alone or combined with targeted drugs (such as lenvatinib) in the treatment of advanced HCC is significantly better than that of targeted monotherapy. The principle of HAIC is that chemotherapeutic drugs are continuously pumped through the hepatic artery through a microcatheter, thereby killing tumor cells and causing tumor shrinkage and necrosis. Although continuous infusion of chemotherapeutic drugs through the hepatic artery can significantly improve the local drug concentration in the tumor, and reduce the toxic and side effects of drugs on the whole body while improving the therapeutic effect, the effect of HAIC is slow. The blood supply of HCC is 95%-99% from the hepatic artery, and abundant blood supply is conducive to the continuous growth of HCC. If transarterial embolization (TAE) can be used to block the blood supply of HCC immediately after HAIC treatment, theoretically, it should further promote the effect of HAIC on tumor cell necrosis, make the tumor quickly reach PR or even CR, obtain the opportunity of hepatic resection, and finally prolong patients' survival time. However, there is still a lack of literature reports on HAIC sequential TAE in the treatment of advanced HCC. Therefore, this project intends to carry out a prospective phase II clinical study to explore the safety and efficacy (ORR, DOR, PFS, OS) of HAIC sequential TAE combined with targeted (lenvatinib) and immunotherapy (tislelizumab) quadruplets, and to screen the best benefit population.
- Conditions
- Liver Cancer
- Being tested
- HAIC sequential TAE combined with lenvatinib and tislelizumab
- Keywords
- hepatocellular carcinoma, hepatic arterial infusion chemotherapy, lenvatinib, tislelizumab
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC sequential TAE combined with lenvatinib and tislelizumabCombination product
Patients with unresectable hepatocellular carcinoma will receive hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab.
| Study group | Role | What they receive |
|---|---|---|
| HAIC sequential TAE combined with lenvatinib and tislelizumab | Experimental | The aim of this phase II trial is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab in patients with unresectable hepatocellular carcinoma (HCC), and to explore the optimal benefit population. Receives: Combination Product: HAIC sequential TAE combined with lenvatinib and tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The primary end-point is the progression-free survival rate per RECIST at six months
Measured: 6 months
Secondary outcomes (2)
Overall survival
Overall survival at two years will be evaluated.
Measured: 2 years
objective response rate
Objective response rate per RECIST will be evaluated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start10 Nov 2022
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- 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
- Model description
- The aim of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab in patients with unresectable hepatocellular carcinoma (HCC), and to explore the optimal benefit population.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
- Investigators
- Le-Qun Li, PhD, Study director, Guangxi Medical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532319
- Sponsor's protocol ID
- FRONT-1
- Acronym
- FRONT-1
- Status last verified
- Dec 2025
- First submitted
- 4 Sep 2022
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data underlying this study will be shared on reasonable request to the corresponding author.
Publications
Lai Z, He M, Bu X, Xu Y, Huang Y, Wen D, Li Q, Xu L, Zhang Y, Wei W, Chen M, Kan A, Shi M. Lenvatinib, toripalimab plus hepatic arterial infusion chemotherapy in patients with high-risk advanced hepatocellular carcinoma: A biomolecular exploratory, phase II trial. Eur J Cancer. 2022 Oct;174:68-77. doi: 10.1016/j.ejca.2022.07.005. Epub 2022 Aug 15.
PubMed 35981413Li QJ, He MK, Chen HW, Fang WQ, Zhou YM, Xu L, Wei W, Zhang YJ, Guo Y, Guo RP, Chen MS, Shi M. Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Transarterial Chemoembolization for Large Hepatocellular Carcinoma: A Randomized Phase III Trial. J Clin Oncol. 2022 Jan 10;40(2):150-160. doi: 10.1200/JCO.21.00608. Epub 2021 Oct 14.
PubMed 34648352He M, Li Q, Zou R, Shen J, Fang W, Tan G, Zhou Y, Wu X, Xu L, Wei W, Le Y, Zhou Z, Zhao M, Guo Y, Guo R, Chen M, Shi M. Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial. JAMA Oncol. 2019 Jul 1;5(7):953-960. doi: 10.1001/jamaoncol.2019.0250.
PubMed 31070690Lyu N, Wang X, Li JB, Lai JF, Chen QF, Li SL, Deng HJ, He M, Mu LW, Zhao M. Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). J Clin Oncol. 2022 Feb 10;40(5):468-480. doi: 10.1200/JCO.21.01963. Epub 2021 Dec 14.
PubMed 34905388
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
- Phase II Trial of Hepatic Arterial inFusion Chemotherapy Sequential transaRterial Embolization cOmbined With leNvatinib and Tislelizumab in Unresectable Hepatocellular Carcinoma (FRONT Trial)
- ClinicalTrials.gov ID
- NCT05532319
- Acronym / sponsor ID
- FRONT-1 / FRONT-1
- Conditions
- Liver Cancer
- Keywords
- hepatocellular carcinoma, hepatic arterial infusion chemotherapy, lenvatinib, tislelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 8 Sep 2022 (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.
Patients with unresectable hepatocellular carcinoma will receive hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab.
Detailed description
In recent years, more and more studies have found that the efficacy of hepatic arterial infusion chemotherapy (HAIC) alone or combined with targeted drugs (such as lenvatinib) in the treatment of advanced HCC is significantly better than that of targeted monotherapy. The principle of HAIC is that chemotherapeutic drugs are continuously pumped through the hepatic artery through a microcatheter, thereby killing tumor cells and causing tumor shrinkage and necrosis. Although continuous infusion of chemotherapeutic drugs through the hepatic artery can significantly improve the local drug concentration in the tumor, and reduce the toxic and side effects of drugs on the whole body while improving the therapeutic effect, the effect of HAIC is slow. The blood supply of HCC is 95%-99% from the hepatic artery, and abundant blood supply is conducive to the continuous growth of HCC. If transarterial embolization (TAE) can be used to block the blood supply of HCC immediately after HAIC treatment, theoretically, it should further promote the effect of HAIC on tumor cell necrosis, make the tumor quickly reach PR or even CR, obtain the opportunity of hepatic resection, and finally prolong patients' survival time. However, there is still a lack of literature reports on HAIC sequential TAE in the treatment of advanced HCC. Therefore, this project intends to carry out a prospective phase II clinical study to explore the safety and efficacy (ORR, DOR, PFS, OS) of HAIC sequential TAE combined with targeted (lenvatinib) and immunotherapy (tislelizumab) quadruplets, and to screen the best benefit population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The aim of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab in patients with unresectable hepatocellular carcinoma (HCC), and to explore the optimal benefit population.
| Arm | Type | Receives |
|---|---|---|
| HAIC sequential TAE combined with lenvatinib and tislelizumab | Experimental | Combination Product: HAIC sequential TAE combined with lenvatinib and tislelizumabThe aim of this phase II trial is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab in patients with unresectable hepatocellular carcinoma (HCC), and to explore the optimal benefit population. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HCC is diagnosed in accordance with the clinical diagnostic criteria of the Guidelines for the Diagnosis and Treatment of primary liver Cancer (2019 edition) issued by the Health Commission of the People's Republic of China or by histopathology;
- ECOG PS 0 or 1;
- Child-Pugh A liver function;
- Chinese Liver Cancer (CNLC) stage IIb, IIIa and IIIb patients, or CNLC stage Ib and IIA patients who cannot undergo hepatectomy for various reasons;
- Expected survival time ≥6 months;
Key exclusion criteria (19 listed)
- Previous or co-existing other malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Previously received HAIC, TACE, TAE, radiofrequency ablation and other local treatments for HCC;
- Patients who have received or are using one of the following three drugs in the previous 6 months: ① immune checkpoint inhibitors, including but not limited to artemizumab, nivolumab, pembrolizumab, camrelizumab, sintilimab, toripalimab, and tislelizumab; ② molecular targeted therapy, including but not limited to sorafenib, lenvatinib, apatinib, regorafenib, anlotinib, bevacizumab, etc. ③ systemic chemotherapy drugs (such as doxorubicin, oxaliplatin, 5-FU, S-1, etc.);
- Having a congenital or acquired immunodeficiency disease (e.g. being HIV positive);
- Active infection, or body temperature ≥ 38.5℃ or white blood cell count > 15 x 10^9/L 7 days before enrollment;
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 |
|---|---|---|
| HAIC sequential TAE combined with lenvatinib and tislelizumabPatients with unresectable hepatocellular carcinoma will receive hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab. | Combination product | HAIC sequential TAE combined with lenvatinib and tislelizumab |
Primary outcome
Progression-free survival
Time frame: 6 months
The primary end-point is the progression-free survival rate per RECIST at six months
2 secondary outcomes
Overall survival
Time frame: 2 years
objective response rate
Time frame: 6 months
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.
- Background: PubMed 35981413Lai Z, He M, Bu X, Xu Y, Huang Y, Wen D, Li Q, Xu L, Zhang Y, Wei W, Chen M, Kan A, Shi M. Lenvatinib, toripalimab plus hepatic arterial infusion chemotherapy in patients with high-risk advanced hepatocellular carcinoma: A biomolecular exploratory, phase II trial. Eur J Cancer. 2022 Oct;174:68-77. doi: 10.1016/j.ejca.2022.07.005. Epub 2022 Aug 15.
- Background: PubMed 34648352Li QJ, He MK, Chen HW, Fang WQ, Zhou YM, Xu L, Wei W, Zhang YJ, Guo Y, Guo RP, Chen MS, Shi M. Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Transarterial Chemoembolization for Large Hepatocellular Carcinoma: A Randomized Phase III Trial. J Clin Oncol. 2022 Jan 10;40(2):150-160. doi: 10.1200/JCO.21.00608. Epub 2021 Oct 14.
- Background: PubMed 31070690He M, Li Q, Zou R, Shen J, Fang W, Tan G, Zhou Y, Wu X, Xu L, Wei W, Le Y, Zhou Z, Zhao M, Guo Y, Guo R, Chen M, Shi M. Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial. JAMA Oncol. 2019 Jul 1;5(7):953-960. doi: 10.1001/jamaoncol.2019.0250.
- Background: PubMed 34905388Lyu N, Wang X, Li JB, Lai JF, Chen QF, Li SL, Deng HJ, He M, Mu LW, Zhao M. Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). J Clin Oncol. 2022 Feb 10;40(5):468-480. doi: 10.1200/JCO.21.01963. Epub 2021 Dec 14.
- Individual participant dataSharing planned: No. The data underlying this study will be shared on reasonable request to the corresponding author.
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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.
Le-Qun Li, PhD study director
Guangxi Medical University Cancer Hospital
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 HAIC sequential TAE combined with lenvatinib and tislelizumab in people with Liver Cancer, run by Guangxi Medical 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 9 inclusion and 19 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?
Progression-free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532319, which also lists 4 linked publications.
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.