BridgeMD
Tests treatment safety and results for Hepatocellular Carcinoma (HCC)
Official title Clinical Study on the Effectiveness and Safety of Lenvatinib As Adjuvant Treatment for Patients with High-risk Recurrence of Hepatocellular Carcinoma After Surgery
ClinicalTrials.gov ID: NCT06762782
What this study is testing
What is Postoperative adjuvant lenvatinib?
Postoperative adjuvant lenvatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, randomized, controlled, open, phase II, multicenter clinical study, which aims to evaluate the efficacy and safety of lenvatinib for adjuvant treatment of high-risk recurrent liver cancer after radical surgery. This study is divided into 3 stages: screening period (screening period 28 days), treatment period (up to 12 months, or until any of the following occurs, whichever occurs first: ① The subject has an intolerable toxic reaction and is still not relieved after dose adjustment; ② The subject's first imaging confirmed disease recurrence or withdrew from the study for other reasons), and follow-up period (12 months after the end of treatment).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Certainly, here is the translation of the provided text into English:
- Age between 18 to 80 years old, gender not limited;
- Received radical treatment surgery for liver cancer within 4 to 8 weeks prior to enrollment, and meet the following criteria: (1) Intraoperative...
- Postoperative pathological examination confirms hepatocellular carcinoma(HCC), and all tumor nodules are completely removed with negative resection...
- Imaging examinations ≥4 weeks after surgery confirm no recurrence or metastasis.
You likely can't join if
- Here is the translation of the provided text into English:
- Pathologically diagnosed as a mixed type of hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC).
- Positive surgical margins or tumor rupture.
- Reoperation for recurrent liver cancer.
- History of other malignancies within 5 years, unless the patient has undergone potentially curative treatment and has no evidence of the disease for...
- Past or current congenital or acquired immunodeficiency diseases.
See the full eligibility criteria
- Certainly, here is the translation of the provided text into English:
- Age between 18 to 80 years old, gender not limited;
- Received radical treatment surgery for liver cancer within 4 to 8 weeks prior to enrollment, and meet the following criteria: (1) Intraoperative judgment criteria: ① No gross tumor thrombus in the hepatic vein, portal...
- Postoperative pathological examination confirms hepatocellular carcinoma(HCC), and all tumor nodules are completely removed with negative resection margins.
- Imaging examinations ≥4 weeks after surgery confirm no recurrence or metastasis.
- Expected survival \>3 months;
- hepatitis B virus(HBV) deoxyribonucleic acid(DNA) \<10\^4 copies/ml (2000 IU/ml), if hepatitis B virus(HBV) deoxyribonucleic acid(DNA) ≥10\^4 copies/ml, antiviral treatment should be initiated first until hepatitis B...
- At least one of the following high recurrence risk factors exists:
- Tumor diameter \>5cm
- Multiple lesions (\>3)
- Pathology indicates MVI positivity
- Edmondson III-IV grade
- Persistently abnormal alpha-fetoprotein 8. No history of other tumors, and no antitumor treatment before surgery; 9. Eastern Cooperative Oncology Group(ECOG) score: 0-1. 10. Major organ functions are normal, i.e...
- Hemoglobin ≥90 g/L;
- Absolute neutrophil count (ANC) ≥1.5×10\^9/L;
- Platelet count ≥75×10\^9/L; Biochemical examination (within 14 days before screening, without the use of albumin):
- Albumin ≥28 g/L;
- Total bilirubin ≤1.5×upper limit of normal (ULN);
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤3×ULN;
- Creatinine ≤1.5×ULN; Coagulation function:
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;
- Activated partial thromboplastin time (APTT) ≤1.5×ULN. 11.Patients with reproductive capacity, both male and female, must use reliable contraceptive measures during the study medication use and for 60 days after the...
- Here is the translation of the provided text into English:
- Pathologically diagnosed as a mixed type of hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC).
- Positive surgical margins or tumor rupture.
- Reoperation for recurrent liver cancer.
- History of other malignancies within 5 years, unless the patient has undergone potentially curative treatment and has no evidence of the disease for 5 years, except for patients who have successfully undergone resection...
- Past or current congenital or acquired immunodeficiency diseases.
- Patients who have undergone allogeneic transplantation.
- Insufficient biopsy and/or surgical samples are unavailable.
- Pregnant and breastfeeding patients.
- Received targeted drug therapy such as sorafenib, lenvatinib, regorafenib, or immunomodulatory therapy such as anti-PD-1, anti-PD-L1, anti-CTLA-4 before surgery.
- Unable to provide informed consent (due to language, intellectual capacity, etc.).
- Active bleeding or coagulation abnormalities, with a tendency to bleed or currently undergoing thrombolytic, anticoagulant, or antiplatelet therapy.
- History of gastrointestinal bleeding within the past 4 weeks or a clear tendency towards gastrointestinal bleeding (e.g., known active local ulcer lesions, fecal occult blood ++ or more, if persistent fecal occult blood...
- Significant clinically meaningful cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within the past 6 months, congestive heart...
- Allergy to chemotherapy drugs or contraindications to surgery.
- History of thrombosis or thromboembolic events within the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.
- History of gastrointestinal perforation, abdominal fistula, or intra-abdominal abscess within the past 6 months.
- Not yet recovered from surgery, such as having unhealed incisions or severe postoperative complications.
- History of alcohol, psychotropic drugs, or other drug abuse within the past 6 months.
- Presence of other serious diseases that the investigator deems unsuitable for participation in this study;
- Currently participating in other therapeutic/treatment clinical trials.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.