primary hepatocellular carcinoma
Conditions
Interventions
Test group:PD-1 inhibitor combined with bevacizumab and TACE
Sponsors
Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Hepatocellular carcinoma confirmed by histology/cytology, or meeting the clinical diagnostic criteria of China's 2022 edition of "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer"; 2. The patient is = 18 years old; 3. Barcelona Clinical Liver Cancer (BCLC) is in phase C; Phase B not suitable for surgery and/or local treatment; 4. There is at least one measurable or evaluable lesion according to the evaluation standard of curative effect of solid tumor version 1.1 (RECIST v1.1); 5. Expected survival time = 12 weeks; 6. According to the physical condition score (ECOG PS score) of the Eastern Cancer Cooperation Group of the United States, it is 0-2 points; 7. Child-Pugh grade A~B; 8. CNLC la, Ib and IIa patients with liver cancer who have indications for surgical resection or ablation, but are unable or unwilling to accept surgical treatment or ablation due to non-operative reasons such as old age, insufficient reserve of liver function, high-risk sites of tumor, etc; 9. CNLC stage IIb, IIIa and some IIIb liver cancer patients; 10. The main portal vein is not completely blocked or the compensatory collateral vessels of the portal vein are abundant or pass through Liver cancer patients with portal vein stent implantation can restore portal vein blood flow; 11. Liver cancer patients with portal hypertension bleeding caused by hepatic artery-portal venous shunt; 12. Patients with high risk recurrence factors (including multiple tumors, combined with tumor thrombus under naked eyes or microscope, palliative surgery, postoperative AFP and other tumor markers not falling to the normal range, etc.) can be treated with adjuvant TACE after resection of liver cancer to reduce recurrence and prolong survival; 13. 1ACE treatment before the initial unresectable liver cancer surgery can achieve transformation, creating opportunities for surgical resection and ablation 14. After evaluation, the researcher planned to give PD-1 inhibitor combined with bevacizumab and TACE treatment scheme; 15. Sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Receive live attenuated vaccine within 4 weeks before enrollment or during the study period; 2. Active, known or suspected autoimmune diseases; 3. Known history of primary immunodeficiency; 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 5. Pregnant or lactating female patients; 6. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition that the number of virus copies of patients receiving antiviral treatment is monitored, the doctor will judge whether they are eligible for enrollment according to the individual conditions of patients; 7. Uncontrolled concurrent diseases, including but not limited to: 1) People infected with HIV (HIV antibody positive) 2) Serious infection in active stage or under clinical control 3) Evidence of serious or uncontrollable systemic diseases (such as serious mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [that is, hypertension is still greater than or equal to CTCAE grade 2 after drug treatment]) 4) Patients with active bleeding or new thrombotic disease who are taking therapeutic anticoagulant drugs or have bleeding tendency have abnormal coagulation function (INR>1.5 × ULNAPTT>1.5 × ULN) 8. Severe impairment of liver function (Child-PughC grade), including jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 9. The main portal vein is completely embolized by tumor thrombus/thrombus, and the formation of collateral vessels is less; 10. Patients with extensive distant metastasis and estimated survival time2mg/dl or blood creatinine clearance rate<30ml/min 14. Those who are currently conducting clinical trials of other drugs; 15. Other patients who are considered unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate;adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Total survival rate;Disease control rate;Time of disease remission; | — |
Countries
China
Contacts
Public ContactHaitao Zhu
Affiliated Hospital of Guizhou Medical University
Outcome results
None listed