Hepatocelluar carcinoma
Conditions
Interventions
Observative group:HAIC combined with Donafenib Toslate Tablets and Sindilimab Injection
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. The patients voluntarily joined the study and signed the informed consent; 3. Hepatocellular carcinoma was not treated with antitumor therapy before radical surgery, including systemic and local therapy; 4. Patients who underwent radical resection and met the criteria for radical resection of liver cancer were pathologically confirmed to have negative resection margins (R0 resection); 5. Postoperative examination confirmed positive MVI; 6. Child-Pugh liver function classification: Grade A or B (=4 weeks after surgery confirmed no recurrence and metastasis; 9. Complete clinical research data; 10. Agree to sign a written consent form; 11. Good compliance and the choice to plan for follow-up, therapy, laboratory tests, and other research procedures.
Exclusion criteria
Exclusion criteria: 1. Have received liver transplantation in the past; 2. Have received systemic treatment for HCC in the past, including chemotherapeutics, sorafenib, lenvatinib, regorafenib and other targeted drug therapy or anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.; 3. Pathologically diagnosed as fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type; 4. A history of malignant tumors, unless the following criteria are met (1) The patient has received possible curative treatment and there is no evidence of the existence of the disease within 5 years; (2) Skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinomas in situ that have successfully received resection; 5. A history of local or systemic anti-tumor therapy for HCC; 6. Suffer from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); 7. Past history of HIV infection; 8. Active infections, including: (1) HIV positive (HIV1/2 antibody); (2) Active hepatitis B (HBsAg positive and abnormal liver function); (3) Active hepatitis C (HCV antibody positive or HCV RNA >=10^3 copies/ml and abnormal liver function); (4) Active tuberculosis; (5) Other uncontrollable active infections (CTCAE V5.0> level 2); 9. Patients who are known or suspected to have a history of allergy to Donafinil or similar drugs, or have a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or who are allergic to the excipients of the study drug; 10. Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures; 11. There is a history of gastrointestinal bleeding or a clear gastrointestinal bleeding tendency in the past 4 weeks (eg: known local active ulcer lesions, stool occult blood++ or more, if persistent stool occult blood+, gastroscopy should be performed) and Other conditions (such as severe gastric fundus/esophageal varices) that may not cause gastrointestinal bleeding as determined by the investigator have not been specifically treated; 12. There has been gastrointestinal perforation, abdominal fistula or abdominal abscess in the past 6 months; 13. There have been thrombosis or thromboembolic events in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc; 14. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass graft in the past 6 months, congestive heart failure (New York Heart Association NYHA grade> 2 ), poorly controlled arrhythmia or need for pacemaker therapy, high blood pressure not controlled by drugs (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg); 15. Received clinical trials of other drugs or medical devices within 4 weeks before enrollment; 16. There is a history of alcohol, psychotropic drug or other drug abuse in the past 6 months; 17. There are other reasons why the researcher believes that they cannot be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year recurrence free survival rate;Overall survival; | — |
Countries
China
Contacts
Public ContactPing Huang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed