Liver Cancer Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | December 31, 2029 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Age between 18 and 75 years inclusive. 2. Histologically confirmed hepatocellular carcinoma without other non-hepatocellular carcinoma components. 3. ECOG performance status 0-1. 4. Child-Pugh class A liver function. 5. Eligible for chemotherapy and targeted therapy within 1-2 months after liver transplantation. 6. Immunosuppressive regimen including calcineurin inhibitors, mycophenolate mofetil, and sirolimus. 7. 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. 8. Negative serum/urine pregnancy test within 7 days prior to treatment initiation for fertile women. 9. Reliable contraception must be used by all male and female participants during the trial and for six months after its completion. 10. Ability to take oral medications. 11. Participants must provide written informed consent. Exclusion Criteria: 1. Life expectancy less than 6 months. 2. High suspicion of hepatocellular carcinoma recurrence and metastasis. 3. Concurrent malignancies. 4. Allergy to lenvatinib or chemotherapy drugs. 5. Pregnant or lactating women (female participants must undergo pregnancy testing within 7 days prior to treatment). 6. 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 (ß-blockers or digoxin permitted); uncontrolled hypertension. 7. History of HIV infection. 8. Severe active clinical infections. 9. Patients requiring medication for epilepsy (e.g., steroids or antiepileptic drugs). 10. Patients with kidney diseases requiring dialysis. 11. 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. 12. Patients unable to swallow oral medications, such as those with severe upper gastrointestinal obstruction requiring gastric tube feeding. 13. Previous treatment with other anti-angiogenic therapies, surgery, TACE, local therapy, systemic chemotherapy, immunotherapy, etc., before liver transplantation. 14. Clear evidence of main portal vein/hepatic vein tumor thrombus or inferior vena cava tumor thrombus. 15. Clear evidence of lymph node metastasis. |
Country | Name | City | State |
---|---|---|---|
China | Organ Transplantation Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | |
Secondary | 2-year overall survival | The cumulative incidence of patients surviving the next 2 years from the start of treatment. | 2 years | |
Secondary | 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. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03756597 -
PAN-study: Pan-Cancer Early Detection Study (PAN)
|
||
Recruiting |
NCT05160740 -
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
|
N/A | |
Completed |
NCT01906021 -
Study of New Software Used During Ablations
|
N/A | |
Terminated |
NCT04589884 -
Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
|
||
Recruiting |
NCT05953337 -
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
|
N/A | |
Enrolling by invitation |
NCT04466124 -
Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy
|
||
Not yet recruiting |
NCT04053231 -
Hepatocarcinoma Recurrence on the Liver Study - Part2
|
||
Active, not recruiting |
NCT02869217 -
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT03059238 -
Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure
|
Phase 3 | |
Recruiting |
NCT02632188 -
Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT01388101 -
Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)
|
N/A | |
Completed |
NCT01042041 -
Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer
|
Phase 1 | |
Terminated |
NCT00903396 -
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
|
Phase 2 | |
Completed |
NCT00980239 -
HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver
|
Phase 1 | |
Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
Completed |
NCT00543777 -
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
|
Phase 1/Phase 2 | |
Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A |