Primary liver cancer
Conditions
Interventions
Study group:Jinlong Capsule combined with neoadjuvant therapy for liver cancer
Control group:Neoadjuvant therapy for liver cancer
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects volunteered to participate in the study, signed the informed consent, had good compliance, and cooperated with follow-up; 2. Aged >= 18 years old, no gender limit; 3. Patients with primary hepatocellular carcinoma, confirmed by histopathology or meeting clinical diagnostic criteria, and it is suitable for surgical resection or oncologically suitable for surgery, with medium or high-risk recurrence factors in CNLC Ib/IIa/IIb/IIIa stage primary liver cancer patients without Vp3 or Vp4 portal vein tumor thrombus; 4. High-risk factors for recurrence include vascular invasion, solitary tumor >5 cm in diameter, multiple tumors, adjacent organ involvement, lymph node metastasis, elevated preoperative AFP level (>400 ng/mL), and high preoperative serum HBV DNA load (>2000 IU/mL); 5. According to the RECIST 1.1 or mRECIST criteria, the patients must have measurable target lesions detected by CT or MRI examination; 6. Child-Pugh Grade A; 7. ECOG score 0-1 points; 8. Hepatitis B virus (HBV) infection: If serum HBsAg positive, HBV-DNA testing should be less than 2000 IU/mL (or = 2000 IU/mL can be enrolled if they have received anti-HBV therapy at least 7 days before enrollment and their viral load has decreased by more than 10 times compared to the baseline; besides, patients should have willingness to receive antiviral therapy throughout the study period. Patients with positive serum hepatitis C virus (HCV)-RNA must receive antiviral therapy according to related guidelines; 9. The main organs are functioning normally, meeting the following criteria: (1) Bone marrow function: absolute neutrophil count (ANC) >=1.5×10^9/L, hemoglobin (Hb) >= 8.0 g/dL, platelet count (PLT) >= 75×10^9/L; (2) Liver function: aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine aminotransferase (ALT) 40 mL/min (calculated by the Cockcroft and Gault formula); (5) Pancreatic function: amylase and lipase <= 1.5 times the upper limit of normal (ULN); (6) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) is within the normal range. If the baseline TSH is outside the normal range, patients with total T3 (or FT3) and FT4 within the normal range can also be enrolled.
Exclusion criteria
Exclusion criteria: 1.Patients with a known diagnosis of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma, and fibrolamellar carcinoma; having other active malignant tumors other than liver cancer within 5 years or simultaneously; 2.Had received more than one operative for hepatocellular carcinoma; 3. Clinically significant cardiovascular or cerebrovascular diseases; 4.Patients who have a history of severe systemic drug induced allergies such as severe skin rashes, active autoimmune diseases, or a history of autoimmune diseases that may relapse; or a history of interstitial pneumonia, interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, and acute lung disease; 5.Clinically significant bleeding events within 6 months before enrollment; 6.A history of Human Immunodeficiency Virus (HIV) infection or other acquired or congenital immunodeficiency diseases, untreated hepatitis infection: HBV DNA > 2000 IU/ml, HCV RNA>10^3 copy/ml, both HBsAg and anti-HCV antibodies positive; 7.Previously received targeted drug therapy such as sorafenib, lenvatinib, regofinib, apatinib, donafinib, or immunocheckpoint inhibitors such as anti-PD-1, anti-PD-L1, and anti-CTLA-4; 8.Taking other Chinese traditional medicines for liver cancer; 9.Having a history of hepatic encephalopathy or liver transplantation; 10.Pregnant or lactating female patients; 11.Other factors that the researchers deemed unsuitable for the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);1-year disease-free survival rate;Pathological Complete Response (pCR);Safety evaluation indicators;Quality of Life Score;R0 resection rate;Chinese Traditional Medicine Syndrome Score; | — |
Countries
China
Contacts
Public ContactZhao Hong
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed