Watch and Wait Versus Surgical Treatment for Clinical Complete Responders After Non-Curative Therapy for Hepatocellular Carcinoma (WATCH)

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Conversion Reaction Read More

Inclusion Criteria:

• Age ≥18 years old.
• Patients with clinical diagnosis of hepatocellular carcinoma without extrahepatic metastasis, and two liver surgeons evaluated as unresectable.
• AFP≥400ug/L before initial treatment.
• Initial treatment is hepatic arterial intervention (chemoembolization/infusion chemotherapy), combined targeted therapy (sorafenib, lenvatinib, donafenib, apatinib, bevacizumab) and immune checkpoint inhibitor therapy (PD-1\PD-L1).
• After transarterial infusion chemotherapy combined with targeted and immunotherapy treatment, the tumor evaluation is clinical complete response, that is, the following two criteria are met: 1. Two consecutive imaging assessments (one month apart) tumor complete response (CR, mRECIST) standard) 2. Two consecutive tumor markers (one month apart) AFP ≤ the upper limit of the normal value
• The patients with clinical complete response were evaluated by two liver surgeons as resectable.
• Normal hematological function (platelets>75×109/L; leukocytes>3.0×109/L; neutrophils>1.5×109/L)
• Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), transaminases ≤ 3 times ULN
• No ascites, normal coagulation function, albumin≥30g/L
• Child-Pugh class A
• Serum creatinine less than 1.5 times the upper limit of normal (ULN)
• ECOG score 0-1
• Life expectancy > 3 months

Exclusion Criteria:

• Received other tumor treatments other than hepatic artery interventional therapy, targeted and immunotherapy
• Any of the following conditions within the first 12 months of the study: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), Pulmonary embolism; ongoing: arrhythmia of grade ≥2 by NCI-CTCAE criteria, QTc prolongation (>450 ms in men, >470 ms in women);
• Renal insufficiency requires peritoneal dialysis or hemodialysis;
• Serious dysfunction of other important organs;
• A second primary malignant tumor was diagnosed in the past;
• Known or new evidence of brain or leptomeningeal lesions; Hemophilia or bleeding tendency, taking anticoagulation therapy such as coumarin derivatives in therapeutic doses;
• Pregnant or lactating women, all female patients of childbearing potential must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative;
• History of previous organ transplantation;
• Known HIV infection;
• Allergy to chemotherapy drugs;
• Patients with other serious acute or chronic physical or psychiatric diseases or abnormal laboratory tests that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results or the investigators consider unsuitable for enrollment.