| Eligibility |
Inclusion Criteria:
1. Age 18 ~ 75 years old (including the threshold value), male or female;
2. Received radical resection of liver cancer 4-8 weeks before enrollment;
3. Pathologically diagnosed as hepatocellular carcinoma and assessed by the investigator
to have a high risk of recurrence;
4. No recurrence or metastasis was confirmed by imaging examination before enrollment;
5. Child-Pugh score of liver function A;
6. Eastern Cooperative Oncology Group (ECOG) physical status (PS) score of 0-1;
7. The expected survival period is not less than 3 months;
8. The doctor's decision to use Donafenib must be done before the patient is enrolled in
the study;
9. For HBV-infected patients, if HBV-DNA is =104copies/ml within 14 days before
enrollment, they should take antiviral treatment (entecavir is recommended), and then
enter the study when it drops to <104copies/ml, and continue antiviral treatment and
monitoring Liver function and serum HBV-DNA level;
10. Have sufficient organ functional reserve
11. Female patients with reproductive potential (referring to nonmenopausal or surgical
sterilization), the serum pregnancy test results must be negative within 7 days before
the administration of the study drug; female or male patients with reproductive
potential, during the use of the study drug And within 60 days after the last dose,
reliable contraceptive measures must be used;
12. Patients are voluntarily enrolled, can provide written informed consent, and can
understand and comply with the experimental protocol, taking medication and follow-up.
Exclusion Criteria:
1. Pathologically diagnosed as mixed hepatocellular carcinoma-intrahepatic
cholangiocarcinoma (HCC-ICC) or fibrolamellar hepatocellular carcinoma;
2. Past or current patients with congenital or acquired immunodeficiency diseases;
3. Active or previously recorded autoimmune diseases or inflammatory diseases, with
vitiligo or asthma that has been completely resolved in childhood, without any
intervention in adulthood can be included;
4. Combined with other liver diseases, including uncontrolled alcoholic hepatitis or
other hepatitis, decompensated liver cirrhosis, severe fatty liver, hereditary liver
disease, liver atrophy, superior vena cava syndrome, portal hypertension.
5. Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as
bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence
of active pneumonia found during chest CT scan screening;
6. Other malignancies within 5 years, unless the patient has received potentially
curative treatment and there is no evidence of the disease within 5 years, but this
time requirement (that is, within 5 years) does not apply to basal cell carcinoma of
the skin that has been successfully resected , skin squamous cell carcinoma,
superficial bladder cancer, cervical carcinoma in situ or other in situ carcinoma
patients;
7. Have a history of serious mental illness in the past;
8. Suffering from diseases that affect the absorption, distribution, metabolism or
clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal
obstruction, malabsorption, etc.);
9. Received major surgery within 4 weeks before enrollment (determined by the
investigator);
10. Patients who have received allogeneic stem cell or solid organ transplantation in the
past, including patients after liver transplantation;
11. Received other anti-tumor systemic therapy before enrollment, including other
traditional Chinese medicines with anti-tumor indications, less than 2 weeks or 5 drug
half-lives (whichever is longer) after the completion of the treatment and before the
drug in this study. , or patients whose adverse events caused by preoperative
treatment did not recover to =CTCAE grade 1;
12. Received other adjuvant therapy after surgery (except antiviral therapy);
13. Systemic immunosuppressive drug therapy has been used within 2 weeks before
enrollment, or systemic immunosuppressive drug therapy is expected to be required
during the study period
14. Concomitant use of drugs that may prolong QTc and/or induce torsades de pointes (Tdp)
or drugs that affect drug metabolism;
15. The patient is known or suspected to have a history of allergy to tyrosine kinase
inhibitor (TKI) drugs and PD-1 drugs, or to the excipients of the study drug;
16. There is uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural
effusion or pericardial effusion;
17. Active bleeding or abnormal coagulation function, bleeding tendency or receiving
thrombolysis, anticoagulation or antiplatelet therapy;
18. There is a history of gastrointestinal bleeding within the past 4 weeks or a clear
tendency of gastrointestinal bleeding (such as: known local active ulcer lesions,
fecal occult blood ++++ or above, such as persistent fecal occult blood+, gastroscopic
examination should be performed), Or other conditions that may cause gastrointestinal
bleeding as determined by the investigator (such as severe gastric fundus/esophageal
varices);
19. Gastrointestinal perforation, abdominal fistula or abdominal abscess occurred within
the past 6 months;
20. Thrombosis or thromboembolic events have occurred in the past 6 months, such as stroke
and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.;
21. Cardiovascular disease with significant clinical significance, including but not
limited to acute myocardial infarction, severe/unstable angina pectoris or coronary
artery bypass grafting within the past 6 months, congestive heart failure (NYHA
classification > grade 2 of the New York Heart Association ), poorly controlled
arrhythmias that require pacemaker therapy, and uncontrolled hypertension (systolic
blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg);
22. Active infection;
23. Other significant clinical and laboratory abnormalities that the investigators
consider to affect the safety evaluation, such as: uncontrolled diabetes mellitus,
chronic kidney disease, peripheral neuropathy of grade II or above (CTCAE V5.0),
abnormal thyroid function, etc.;
24. Have not recovered from surgery, such as unhealed incisions or serious postoperative
complications;
25. Pregnant or breastfeeding women, as well as female or male patients with reproductive
potential who are unwilling or unable to take effective contraceptive measures;
26. History of alcohol, psychotropic or other drug abuse within the past 6 months;
27. Received clinical trials of other drugs or medical devices within 4 weeks before
enrollment;
28. Unable to follow the research protocol to receive treatment or follow up regularly;
29. Any other researchers who think that they cannot be included in the group
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