Hepatocellular carcinoma
Conditions
Interventions
HAIC combined with Donafinil and Sintilimab group:HAIC and Donafinil 0.1g, bid and Sintilimab 200mg, Q3w
Sponsors
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years; 2. Sign informed consent and be willing to participate in this study; 3. The life expectancy is more than 12 weeks; 4. Patients diagnosed clinically or pathologically / cytologically as hepatocellular carcinoma according to the code for diagnosis and treatment of primary liver cancer (2019 Edition); 5. According to the standard for diagnosis and treatment of primary liver cancer (2019 Edition), the stage is stage IA-IIB, and the tumor size plus the number of tumors is >= 7, or stage IIIA; 6. The investigator judged that the patient was not suitable for radical surgical treatment; 7. According to the evaluation standard of solid tumor curative effect (according to RECIST 1.1 standard, the long diameter of CT scanning of tumor lesions is >= 10 mm, and the short diameter of CT scanning of lymph node lesions is >= 15 mm), at least one imaging measurable lesion; 8. Newly diagnosed hepatocellular carcinoma patients who have not received any local or systematic treatment for hepatocellular carcinoma in the past; 9. ECOG PS score 0 or 1; 10. Child-Pugh score <= 7.
Exclusion criteria
Exclusion criteria: 1. It was pathologically diagnosed as fibrolamellar HCC, sarcomatoid HCC or hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC); 2. Previous liver transplantation; 3. Have received systematic treatment for HCC in the past, including targeted drug treatment such as chemotherapy, sorafenib, renvatinib and regofinib, or immunomodulator treatment such as anti-PD-1, anti-PD-L1 and anti-CTLA-4, except antiviral treatment; 4. Decompensation of liver function; 5. Previous serious mental history; 6. Suffering from diseases affecting the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.); 7. Have a history of gastrointestinal hemorrhage or have a clear tendency of gastrointestinal bleeding in the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Overall Survival (OS);Disease Control Rate (DCR);Duration of response (DOR);Conversion resection rate; | — |
Countries
China
Contacts
Public ContactWanguang Zhang
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed