Liver CancerPhase 1/2NCT06409637
FOLFOX Plus Lenvatinib Adjuvant Therapy for Hepatocellular Carcinoma Post-Liver Transplantation
A Phase 1/2 study testing FOLFOX4 regimen and lenvatinib in people with Liver Cancer and Liver Transplant, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Liver transplantation not only removes the liver tumor (seed) but also eliminates the underlying diseased liver (soil), making it an essential therapeutic approach for hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer, Liver Transplant
- What is being tested?
- FOLFOX4 regimen and lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2029
- Phase
- Phase 1/2
- 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
Who may be able to join
- Age between 18 and 75 years inclusive.
- Histologically confirmed hepatocellular carcinoma without other non-hepatocellular carcinoma components.
- ECOG performance status 0-1.
- Child-Pugh class A liver function.
- Eligible for chemotherapy and targeted therapy within 1-2 months after liver transplantation.
- Immunosuppressive regimen including calcineurin inhibitors, mycophenolate mofetil, and sirolimus.
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- Adequate liver, kidney, and bone marrow function: serum albumin >28g/L, total bilirubin ≤3mg/dL (51.3 umol/l), ALT and AST ≤5 times the upper limit of normal; serum creatinine ≤1.5 times the upper limit of normal; hemoglobin >90g/L, absolute neutrophil count (ANC) >1.5×10^9/L, platelet count >60×10^9/L; PT-INR <1.5 or PT within normal limits +6 seconds.
- Negative serum/urine pregnancy test within 7 days prior to treatment initiation for fertile women.
- Reliable contraception must be used by all male and female participants during the trial and for six months after its completion.
- Ability to take oral medications.
- Participants must provide written informed consent.
Who cannot join
- Life expectancy less than 6 months.
- High suspicion of hepatocellular carcinoma recurrence and metastasis.
- Concurrent malignancies.
- Allergy to lenvatinib or chemotherapy drugs.
- Pregnant or lactating women (female participants must undergo pregnancy testing within 7 days prior to treatment).
- History of severe cardiovascular diseases: congestive heart failure >NYHA class 2; active coronary artery disease (myocardial infarction within 6 months prior to enrollment); severe arrhythmias requiring antiarrhythmic therapy (β-blockers or digoxin permitted); uncontrolled hypertension.
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- History of HIV infection.
- Severe active clinical infections.
- Patients requiring medication for epilepsy (e.g., steroids or antiepileptic drugs).
- Patients with kidney diseases requiring dialysis.
- Drug abuse, medical conditions, psychiatric illnesses, or social status that may interfere with the participant's participation in the study or evaluation of study results.
- Patients unable to swallow oral medications, such as those with severe upper gastrointestinal obstruction requiring gastric tube feeding.
- Previous treatment with other anti-angiogenic therapies, surgery, TACE, local therapy, systemic chemotherapy, immunotherapy, etc., before liver transplantation.
- Clear evidence of main portal vein/hepatic vein tumor thrombus or inferior vena cava tumor thrombus.
- Clear evidence of lymph node metastasis.
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
Organ Transplantation Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University,
Guangzhou, Guangdong, 376032
About this study
Official title: A Prospective, Single-arm Clinical Study of FOLFOX Combined With Lenvatinib as Adjuvant Chemotherapy to Prevent Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma Beyond Milan Criteria
Liver transplantation not only removes the liver tumor (seed) but also eliminates the underlying diseased liver (soil), making it an essential therapeutic approach for hepatocellular carcinoma (HCC). However, the tumor recurrence post-liver transplantation significantly jeopardizing the long-term survival of transplant recipients. Given the scarcity of donor livers, exploring effective measures to prevent tumor recurrence after liver transplantation holds significant clinical and societal value. Currently, there is no consensus on adjuvant therapy for preventing tumor recurrence post-liver transplantation for HCC, and the quantity and quality of studies on systemic chemotherapy are limited. In recent years, administration of the FOLFOX regimen combined with lenvatinib has been widely used in the treatment of advanced HCC, showing remarkable efficacy. The aim of this study is to investigate the efficacy and safety of adjuvant chemotherapy with FOLFOX combined with lenvatinib in preventing tumor recurrence after liver transplantation for HCC beyond Milan criteria.
- Conditions
- Liver Cancer, Liver Transplant
- Being tested
- FOLFOX4 regimen, lenvatinib
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX4 regimenDrug
Also called Oxaliplatin, Leucovorin, 5-Fluorouracil
FOLFOX4 regimen: Oxaliplatin 85mg/m2 intravenous infusion over 2 hours on Day 1; Leucovorin 400mg/m2 intravenous infusion over 2 hours on Days 1-2; 5-Fluorouracil (5-FU) initially 400mg/m2 intravenous bolus followed by 2400mg/m2 continuous intravenous infusion over 46 hours. Each cycle lasts for 4 weeks, repeated every 4 weeks for a total of 6-8 cycles.
lenvatinibDrug
Also called lenvatinib pill
Lenvatinib: For patients with a body weight <60 kg, the recommended daily dose of lenvatinib is 8 mg (2 capsules of 4 mg each), once daily; for patients with a body weight ≥60 kg, the recommended daily dose of lenvatinib is 12 mg (3 capsules of 4 mg each), once daily. Treatment should be continued until disease progression, intolerable adverse effects, or the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX plus Lenvatinib | Experimental | FOLFOX4 regimen: Oxaliplatin 85mg/m2 intravenous infusion over 2 hours on Day 1; Leucovorin 400mg/m2 intravenous infusion over 2 hours on Days 1-2; 5-Fluorouracil (5-FU) initially 400mg/m2 intravenous bolus followed by 2400mg/m2 continuous intravenous infusion over 46 hours. Each cycle lasts for 4 weeks, repeated every 4 weeks for a total of 6-8 cycles.
Lenvatinib: For patients with a body weight <60 kg, the recommended daily dose of lenvatinib is 8 mg (2 capsules of 4 mg each), once daily; for patients with a body weight ≥60 kg, the recommended daily dose of lenvatinib is 12 mg (3 capsules of 4 mg each), once daily. Treatment should be continued until disease progression, intolerable adverse effects, or the end of the study. Receives: Drug: FOLFOX4 regimen; Drug: lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival
From the date of transplantation to the date of tumor recurrence or the date of tumor progression otherwise, with censoring at the date of death or last contact for event-free patients.
Measured: 2 years
Secondary outcomes (2)
2-year overall survival
The cumulative incidence of patients surviving the next 2 years from the start of treatment.
Measured: 2 years
Adverse event and validation of adverse event incidence
The grade and incidence of adverse events (including laboratory tests, vital signs, electrocardiogram and other safety-related indicators, especially hematological system toxicity, liver transplantation function impairment, etc.) during the study, as well as the incidence of serious adverse events.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leibo Xu, PhD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409637
- Sponsor's protocol ID
- SYSKY-2024-167-01
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Clinical Study of FOLFOX Combined With Lenvatinib as Adjuvant Chemotherapy to Prevent Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma Beyond Milan Criteria
- ClinicalTrials.gov ID
- NCT06409637
- Acronym / sponsor ID
- SYSKY-2024-167-01
- Conditions
- Liver Cancer, Liver Transplant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 May 2024 (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.
Liver transplantation not only removes the liver tumor (seed) but also eliminates the underlying diseased liver (soil), making it an essential therapeutic approach for hepatocellular carcinoma (HCC). However, the tumor recurrence post-liver transplantation significantly jeopardizing the long-term survival of transplant recipients. Given the scarcity of donor livers, exploring effective measures to prevent tumor recurrence after liver transplantation holds significant clinical and societal value. Currently, there is no consensus on adjuvant therapy for preventing tumor recurrence post-liver transplantation for HCC, and the quantity and quality of studies on systemic chemotherapy are limited. In recent years, administration of the FOLFOX regimen combined with lenvatinib has been widely used in the treatment of advanced HCC, showing remarkable efficacy. The aim of this study is to investigate the efficacy and safety of adjuvant chemotherapy with FOLFOX combined with lenvatinib in preventing tumor recurrence after liver transplantation for HCC beyond Milan criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOX plus Lenvatinib | Experimental | Drug: FOLFOX4 regimen, Drug: lenvatinibFOLFOX4 regimen: Oxaliplatin 85mg/m2 intravenous infusion over 2 hours on Day 1; Leucovorin 400mg/m2 intravenous infusion over 2 hours on Days 1-2; 5-Fluorouracil (5-FU) initially 400mg/m2 intravenous bolus followed by 2400mg/m2 continuous intravenous infusion over 46 hours. Each cycle lasts for 4 weeks, repeated every 4 weeks for a total of 6-8 cycles. Lenvatinib: For patients with a body weight <60 kg, the recommended daily dose of lenvatinib is 8 mg (2 capsules of 4 mg each), once daily; for patients with a body weight ≥60 kg, the recommended daily dose of lenvatinib is 12 mg (3 capsules of 4 mg each), once daily. Treatment should be continued until disease progression, intolerable adverse effects, or the end of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 and 75 years inclusive.
- Histologically confirmed hepatocellular carcinoma without other non-hepatocellular carcinoma components.
- ECOG performance status 0-1.
- Child-Pugh class A liver function.
- Eligible for chemotherapy and targeted therapy within 1-2 months after liver transplantation.
Key exclusion criteria (15 listed)
- Life expectancy less than 6 months.
- High suspicion of hepatocellular carcinoma recurrence and metastasis.
- Concurrent malignancies.
- Allergy to lenvatinib or chemotherapy drugs.
- Pregnant or lactating women (female participants must undergo pregnancy testing within 7 days prior to 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 |
|---|---|---|
| FOLFOX4 regimenAlso: Oxaliplatin, Leucovorin, 5-FluorouracilFOLFOX4 regimen: Oxaliplatin 85mg/m2 intravenous infusion over 2 hours on Day 1; Leucovorin 400mg/m2 intravenous infusion over 2 hours on Days 1-2; 5-Fluorouracil (5-FU) initially 400mg/m2 intravenous bolus followed by 2400mg/m2 continuous intravenous infusion over 46 hours. Each cycle lasts for 4 weeks, repeated every 4 weeks for a total of 6-8 cycles. | Drug | FOLFOX plus Lenvatinib |
| lenvatinibAlso: lenvatinib pillLenvatinib: For patients with a body weight <60 kg, the recommended daily dose of lenvatinib is 8 mg (2 capsules of 4 mg each), once daily; for patients with a body weight ≥60 kg, the recommended daily dose of lenvatinib is 12 mg (3 capsules of 4 mg each), once daily. Treatment should be continued until disease progression, intolerable adverse effects, or the end of the study. | Drug | FOLFOX plus Lenvatinib |
Primary outcome
2-year recurrence-free survival
Time frame: 2 years
From the date of transplantation to the date of tumor recurrence or the date of tumor progression otherwise, with censoring at the date of death or last contact for event-free patients.
2 secondary outcomes
2-year overall survival
Time frame: 2 years
Adverse event and validation of adverse event incidence
Time frame: 2 years
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 10 May 2024.
- 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.
Leibo Xu, PhD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FOLFOX4 regimen and lenvatinib in people with Liver Cancer and Liver Transplant, run by Sun Yat-Sen Memorial Hospital of 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 11 inclusion and 15 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 10 May 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 Leibo Xu, PhD (18819182396 ext. +86, xuleibo3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival (time frame: 2 years). 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 10 May 2024.