Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC

Korábbi kezelés

• Previous abdominal radiotherapy and liver transplantation;
• Suspected or indeed drug abusers, drug abusers and alcoholics;

Más betegség

• Patients with severe chronic diseases of heart, kidney, liver and other important organs;
• Allergic to lenvatinib or other treatments.
• Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction

Egyéb

• Currently in the process of other clinical trials within recently four weeks;
• Pregnant or lactating women;

• Patients had an HCC diagnosis confirmed either histologically or clinically according to the Chinese Society of Clinical Oncology guidelines for primary liver cancer 2019 version；
• Aged ≥18 years and <80 years；
• ECOG 0-1;
• Live-GTV volume > 700ml;
• BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning);
• Estimated life expectancy should be more than 3 months;
• Patients with lung and / or bone metastases can be enrolled if those metastases couldn't effect the patients' life and quality of life within 3 months;
• Child-Pugh Score A5,A6,B7;
• Liver function: ALT is less than 1.5 times of the upper limit of normal; ALT is less than 0.5 times of the upper limit of normal, AST can be less than 6 times of the upper limit of normal, excluding the elevation of AST caused by heart infarction; ALT is 0.5 to 1.5 times of the upper limit of normal, AST is less than 1.5 times of the upper limit of normal;
• ECG examination showed no obvious abnormality, no obvious cardiac dysfunction;
• Renal function: CRE and BUN were within 1.5 times of the upper limit of normal value;
• Blood routine: HB ≥ 80g / L, ANC ≥ 1.0 × 109 / L, PLT ≥ 40 × 109 / L;
• Coagulation function: no bleeding tendency;
• Informed and voluntarily participated in the study and signed informed consent.