hepatocellular carcinoma
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The age at the date of obtaining the consent is 20 years or older 2.ECOG performance status is 0 or 1 3.Hepatocellular carcinoma has been diagnosed by abdominal ultrasonography, contrast-enhanced CT scan, contrast-enhanced MRI imaging*1 or histopathological examination. 4.Diagnosed with either a. through d. within 60 days prior to enrollment*2. a. Clinical stage IA hepatocellular carcinoma (T1aN0M0) b. Clinical stage IB hepatocellular carcinoma (T1bN0M0) c. Clinical stage II hepatocellular carcinoma (T2N0M0) d. Clinical stage IIIA hepatocellular carcinoma (T3N0M0) 5.No treatment prior to enrollment for hepatocellular carcinoma with eligibility criteria 3-4. and hepatic resection or ablation is planned after enrollment. 6.Child-Pugh score classification of A or B. 7.Willingness to submit blood and tissue specimens in accordance with the research protocol. 8.Consent has been obtained in writing. *1 Abdominal ultrasound, contrast-enhanced CT or contrast-enhanced MRI imaging studies are all acceptable. However, it is preferable that all imaging tests be performed and comprehensively evaluated. *2 A thoracoabdominal and pelvic CT or MRI scan to evaluate lymph node metastases and to exclude distant metastases must be performed. *3 In cases where ablation is being contemplated, transcatheter arterial chemoembolization (TACE) or transcatheter arterial embolization (TAE) may be performed prior to ablation as an additional treatment.
Exclusion criteria
Exclusion criteria: 1. a history of malignancy (excluding intraepithelial cancer) with a disease-free period of 5 years or less. *1 2. Clinically diagnosed cancer of another organ. 3. the presence of multiple tumors for which different treatments of hepatic resection and ablation are contemplated for each. 4. Preoperative adjuvant therapy is contemplated prior to liver resection or ablation.*2 5.women who are pregnant or intend to become pregnant. 6. deemed unsuitable for enrollment in the study by the attending physician. *1 Even if the disease-free period is less than 5 years, a history of cancer with a 5-year relative survival rate equivalent to 95% or higher, such as stage I prostate cancer, stage 0 and stage I laryngeal cancer with complete response to radiotherapy, and the following pathological stages of cancer that have been completely resected, can be registered without exclusion. Gastric cancer (adenocarcinoma (general type)): stage 0-I, colon cancer (adenocarcinoma): stage 0-I, rectal cancer (adenocarcinoma): stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, basal cell carcinoma): stage 0, breast cancer (non-invasive ductal carcinoma, non-invasive lobular carcinoma): stage 0, breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): stage 0-IIA Uterine cancer (endometrial adenocarcinoma, mucinous adenocarcinoma): stage IA, Prostate cancer (adenocarcinoma): stage I-II, Cervical cancer (squamous cell carcinoma): stage IA, Thyroid cancer (papillary carcinoma, follicular carcinoma): stage I, II, III, Renal cancer (panniculocarcinoma, anaplastic pigment cell carcinoma): stage I, Other intramucosal cancer equivalent lesions *2 Postoperative adjuvant therapy after liver resection or ablation is contemplated is acceptable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive rates of LUNAR assay in stage IA-IIIA hepatocellular carcinoma | — |
Countries
Japan
Contacts
Public ContactYoshiaki Nakamura
National Cancer Center Hospital East Division for the Promotion of Drug and Diagnostic Development
Outcome results
None listed