Hepatocellular CarcinomaPhase 2/3NCT05250843
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC
A Phase 2/3 study testing TACE/HAIC, Lenvatinib and Sintilimab in people with Hepatocellular Carcinoma, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TACE/HAIC, Lenvatinib and Sintilimab
- 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
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to 30 Dec 2024
- Phase
- Phase 2/3
- 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
- 1) Age 18-70 years old, gender is not limited.
- 2)The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
- 3)Patients must have at least one tumor lesion that can be accurately measured.
- 4)Conform to any of the following criteria (1) multiple nodules >3; (2) ≥2 nodules, any of which is >3 cm; (3) invasion of the portal vein or hepatic vein.
- 5)According to the 2022 edition of the Chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group
- 6)No previous anti-HCC treatment.
- 7)Eastern Co-operative Group performance status 2 or less.
- 8)Liver function: Child's A or B (score < 7).
Who cannot join
- 1)Patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava;
- 2) Allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs;
- 3) Local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Yang Yang, PHD, MD, 020-85252113, yysysu@163.com
Yingcai Zhang, PHD, MD, 76207884@qq.com
About this study
Official title: TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Patients With Potentially High Recurrence Risk After Liver Cancer Resection: a Prospective, Randomized, Controlled Clinical Study
The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.
Read the detailed description
For patients with hepatocellular carcinoma staged BCLC B/C(intermediate hepatocellular carcinoma)，TACE is a widely used treatments .However ,The efficacy of TACE in intermediate hepatocellular carcinoma is not very satisfactory.A series of study demonstrated that direct hepatectomy has better prognosis compared with TACE for these intermediate hepatocellular carcinoma patients.Despite of this ,The high recurrence risk, high probability of surgical complications, and poor treatment effect after recurrence of intermediate hepatocellular carcinoma after direct surgical treatment is a still a tough problem to be solved.Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver .In addition, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma.In this context，for those patients with potentially high recurrence risk after liver resection, the investigators carried out this prospective randomized control to demonstrate the superiority of TACE/HAIC combined with PD-1 antibody and lenvatinib as a neoadjuvant therapy before liver resection over direct hepatectomy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE/HAIC, Lenvatinib, Sintilimab, liver resection
- Keywords
- Lenvatinib, TACE, PD-1
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE/HAICProcedure or surgery
Within 1-3 days of lenvatinib and sintilimab, start Transarterial chemobolization treatment or FOLFOX-based chemotherapy infusion,after three months,patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection.
LenvatinibDrug
Participants received lenvatinib capsules 8mg for patients weight <60kg, or 12mg for patients weight more than 60Kg.
SintilimabDrug
Sintilimab Injection will be administered every three weeks (200mg) until surgery or disease progression.
liver resectionProcedure or surgery
liver resection is feasible after evaluation by the liver cancer surgery expert group
| Study group | Role | What they receive |
|---|---|---|
| TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection | Experimental | For patients staged BCLC B/C,TACE/HAIC combined with Lenvatinib and Sintilimab will be conducted as neoadiuvent therapy before liver resection Receives: Procedure: TACE/HAIC; Drug: Lenvatinib; Drug: Sintilimab |
| Direct surgery group | Active comparator | After being diagnosed with hepatocellular carcinoma, surgery will be immediately performed. Receives: Procedure: liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival
Time from the start of liver resection until tumor recurrence or death (from any cause).
Measured: 12 months
Secondary outcomes (1)
Adverse effects
Frequency and severity of adverse effects as defined by CTCAE version 5
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start30 May 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Yingcai, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250843
- Sponsor's protocol ID
- LHuanxian
- Status last verified
- Oct 2023
- First submitted
- 15 Feb 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Patients With Potentially High Recurrence Risk After Liver Cancer Resection: a Prospective, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05250843
- Acronym / sponsor ID
- LHuanxian
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Lenvatinib, TACE, PD-1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Feb 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.
The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.
Detailed description
For patients with hepatocellular carcinoma staged BCLC B/C(intermediate hepatocellular carcinoma)，TACE is a widely used treatments .However ,The efficacy of TACE in intermediate hepatocellular carcinoma is not very satisfactory.A series of study demonstrated that direct hepatectomy has better prognosis compared with TACE for these intermediate hepatocellular carcinoma patients.Despite of this ,The high recurrence risk, high probability of surgical complications, and poor treatment effect after recurrence of intermediate hepatocellular carcinoma after direct surgical treatment is a still a tough problem to be solved.Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver .In addition, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma.In this context，for those patients with potentially high recurrence risk after liver resection, the investigators carried out this prospective randomized control to demonstrate the superiority of TACE/HAIC combined with PD-1 antibody and lenvatinib as a neoadjuvant therapy before liver resection over direct hepatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection | Experimental | Procedure: TACE/HAIC, Drug: Lenvatinib, Drug: SintilimabFor patients staged BCLC B/C,TACE/HAIC combined with Lenvatinib and Sintilimab will be conducted as neoadiuvent therapy before liver resection |
| Direct surgery group | Active comparator | Procedure: liver resectionAfter being diagnosed with hepatocellular carcinoma, surgery will be immediately performed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1) Age 18-70 years old, gender is not limited.
- 2)The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
- 3)Patients must have at least one tumor lesion that can be accurately measured.
- 4)Conform to any of the following criteria (1) multiple nodules >3; (2) ≥2 nodules, any of which is >3 cm; (3) invasion of the portal vein or hepatic vein.
- 5)According to the 2022 edition of the Chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group
Key exclusion criteria (3 listed)
- 1)Patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava;
- 2) Allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs;
- 3) Local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months
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 |
|---|---|---|
| TACE/HAICWithin 1-3 days of lenvatinib and sintilimab, start Transarterial chemobolization treatment or FOLFOX-based chemotherapy infusion,after three months,patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection. | Procedure or surgery | TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection |
| LenvatinibParticipants received lenvatinib capsules 8mg for patients weight <60kg, or 12mg for patients weight more than 60Kg. | Drug | TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection |
| SintilimabSintilimab Injection will be administered every three weeks (200mg) until surgery or disease progression. | Drug | TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection |
| liver resectionliver resection is feasible after evaluation by the liver cancer surgery expert group | Procedure or surgery | Direct surgery group |
Primary outcome
Recurrence-free Survival
Time frame: 12 months
Time from the start of liver resection until tumor recurrence or death (from any cause).
1 secondary outcome
Adverse effects
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TACE/HAIC, Lenvatinib and Sintilimab in people with Hepatocellular Carcinoma, run by Third Affiliated Hospital, 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survival (time frame: 12 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 13 Oct 2023.