Hepatocellular Carcinoma Non-resectablePhase 2NCT06904183
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT
A Phase 2 study testing LEN+SIN+DEB-TACE+HAIC and LEN+SIN+DEB-TACE in people with Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- LEN+SIN+DEB-TACE+HAIC and LEN+SIN+DEB-TACE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Mar 2030
- 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
- a confirmed diagnosis of HCC
- the largest intrahepatic lesion >7 cm
- presence of PVTT on imaging
- tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
- Eastern Cooperative Oncology Group performance status ≤1
- Child-Pugh class A/B
- adequate hematologic and organ function, with leukocyte count>3.0×10^9/L, neutrophil count>1.5×10^9/L, platelet count≥75×10^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds
- life expectancy of at least 3 months
Who cannot join
- accompanied with vena cava tumor thrombus
- central nervous system involvement
- previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
- organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
- history of other malignancies
- uncontrollable infection
- history of HIV
- history of organ or cells transplantation
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
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Mingyue Cai, Dr., +86-20-34156205, cai020@yeah.net
Kangshun Zhu, Dr., +86-20-34156205, zhksh010@163.com
About this study
Official title: Lenvatinib, Sintilimab, and Drug-Eluting Beads Transarterial Chemoembolization With or Without Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma >7 cm With Portal Vein Tumor Thrombus: A Multicenter, Randomized Controlled Trial
This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (> 7cm) with portal vein tumor thrombosis (PVTT).
Read the detailed description
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of LEN+SIN+DEB-TACE+HAIC compared with LEN+SIN+DEB-TACE for unresectable large HCC (>7cm) with PVTT.
320 patients with large HCC (> 7cm) and PVTT will be enrolled in this study. The patients will receive either Len+DEB-TACE+HAIC or Len+DEB-TACE using an 1:1 randomization scheme. In the LEN+SIN+DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs (oxaliplatin, fluorouracil and leucovorin; FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. DEB-TACE+HAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the LEN+SIN+DEB-TACE arm, patients will be treated with DEB-TACE alone. TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In both arms, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started within 7 days after the first DEB-TACE+HAIC/DEB-TACE.
The primary end point of this study is time to progression (TTP). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS), and adverse events (AEs).
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- LEN+SIN+DEB-TACE+HAIC, LEN+SIN+DEB-TACE
- Keywords
- hepatocellular carcinoma, lenvatinib, transarterial chemoembolization, drug-eluting bead, hepatic arterial infusion chemotherapy, portal vein tumor thrombosis, sintilimab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEN+SIN+DEB-TACE+HAICCombination product
For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered. During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE+HAIC.
LEN+SIN+DEB-TACECombination product
For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE.
| Study group | Role | What they receive |
|---|---|---|
| LEN+SIN+DEB-TACE+HAIC | Experimental | Patients will receive the combination treatment of LEN+SIN+DEB-TACE+HAIC. Receives: Combination Product: LEN+SIN+DEB-TACE+HAIC |
| LEN+SIN+DEB-TACE | Active comparator | Patients will receive the combination treatment of LEN+SIN+DEB-TACE. Receives: Combination Product: LEN+SIN+DEB-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
The time from date of randomization until the first occurrence of disease progression (according to mRECIST).
Measured: 4 years
Secondary outcomes (4)
Objective response rate (ORR)
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST.
Measured: 4 years
Disease control rate (DCR)
The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST.
Measured: 4 years
Overall survival (OS)
The time from date of randomization to death due to any cause.
Measured: 5 years
Adverse Events (AEs)
Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Measured: 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Guangdong Medical University, Zhongshan People's Hospital, Guangdong, China, Huizhou Municipal Central Hospital, Jieyang People's Hospital, Guangzhou Development District Hospital, First People's Hospital of Foshan, Anqing Municipal Hospital, Jinan University Affiliated Shunde Hospital
- Responsible party
- Sponsor
- Investigators
- Kangshun Zhu, Dr., Study chair, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904183
- Sponsor's protocol ID
- MIIR-25
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No