hepatocellular cancer
Conditions
Interventions
Research group:TACE in collaboration with AK104 and Regorafenib
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participates in this study, signs a written informed consent form, and is able to comply with the visit and related procedures stipulated in the protocol. 2. Patients with unresectable hepatocellular carcinoma who have been treated with a combination therapy of PD (L) -1 inhibitors on the first line, who have been histologically/cytologically diagnosed with hepatocellular carcinoma, or who meet the clinical diagnostic criteria of the Chinese Primary Liver Cancer Diagnosis and Treatment Guidelines (2022 edition), and whose stages (CNLC) are IIa, IIb, IIIa, or IIIb, are not suitable for curative treatment such as resection, ablation, or liver transplantation. 3. Age = 18 years old and = 75 years old. 4. Have not received CTLA-4 inhibitor treatment in the past; 5. The main trunk of the portal vein is not completely blocked, or although it is completely blocked, there are compensatory collateral vessels of the portal vein. 6. Suitable for TACE surgery and chemotherapy drugs predetermined by the research center, with no contraindications. 7. The Child Pugh score is A level or a better B level (i.e. B7). According to RECIST v1 1 standard, there must be at least one measurable lesion. 9. ECOG PS is 0-1 points. 10. If the subject is infected with HBV or HCV, the following criteria must be met: 1) HBV infected subjects (HBsAg or HBV-DNA positive): HBV infected subjects should receive antiviral treatment recommended by the guidelines for at least 3 days of continuous treatment before the first treatment, and there should be a decrease in HBV-DNA upon reexamination. During the research period, it is necessary to continue receiving standardized antiviral treatment. 2) HCV infected subjects (HCVAb or HCV RNA positive): According to the researcher's judgment, they are in a stable state. If they are receiving antiviral treatment, they should continue to receive treatment during the study period. 11. It has sufficient organ and bone marrow functions (no blood components, cell growth factors, albumin, or other corrective treatment drugs are allowed to be given within the first 7 days of obtaining laboratory examination), as follows: 1) Blood routine: Absolute neutrophil count (ANC) = 1.5× 109/L; Platelet count (PLT) = 75 × 109/L; Hemoglobin (HGB) = 85 g/L. 2) Liver function: serum total bilirubin (TBIL) = 2 x upper limit of normal value (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 x ULN; Serum albumin = 28 g/L; Amylase (AMS) and lipase (LIP) = 1.5 × ULN. 3) Renal function: serum creatinine (Cr) = 1.5 x ULN, or creatinine clearance rate (CCr) = 40mL/min for subjects with creatinine<1.5 x ULN (Cockcroft Goult formula); The urine routine results showed that urine protein<2+; For patients whose baseline urine routine test shows urine protein = 2+, 24-hour urine collection should be performed and the 24-hour urine protein quantification should be less than 1g. 4) Coagulation function: International standardized ratio (INR) = 2, or activated partial thromboplastin time APTT = 1.5 x ULN. 12. The expected lifespan exceeds 3 months. 13. Female subjects with fertility must undergo a urine or serum pregnancy test within 3 days before the first treatment (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail). If a female subject with fertility engages in sexual activity with an unsterilized male partner, the su
Exclusion criteria
Exclusion criteria: 1. Components such as fibroblastic hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology. 2. The lesion accounts for = 70% of the liver volume. 3. Has a history of liver transplantation or is currently a candidate for liver transplantation. 4. The main trunk of the portal vein and its left and right primary branches all have cancer thrombus blockage, or there is a cancer thrombus in the inferior vena cava, which affects the superior mesenteric vein or further away. 5. History of hepatic encephalopathy. 6. Screening period examination to determine the presence of ascites that require clinical treatment. 7. There are bleeding events within 6 months before the first treatment, such as esophageal or gastric variceal bleeding caused by portal hypertension. Subjects with esophageal or gastric varices who require intervention treatment within 28 days prior to the first intervention treatment. Researchers believe that there is a high risk of bleeding for untreated or untreated esophageal or gastric varices. Active gastric ulcer or duodenal ulcer. 8. Inability to swallow medication, malabsorption syndrome, or any condition that affects the gastrointestinal absorption of lenvatinib. 9. The subjects are unable to undergo enhanced liver CT or MRI scans. 10. Subjects who have previously received systemic anti-tumor therapy with regorafenib for hepatocellular carcinoma. 11. Have received local treatment for the liver (such as TACE, transarterial embolization, TARE, hepatic artery perfusion, or radiation therapy), except for liver lesions that have received local treatment without tumor activity and are not targeted. Excluding newly measurable active lesions that have undergone local treatment in the past. 12. Participated in clinical trials of other drugs within 4 weeks prior to the first treatment. 13. Within 4 weeks before the first treatment or during the study period, plan to receive live or attenuated vaccines. 14. A history of arterial and venous thromboembolism occurring within 6 months prior to the first treatment, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolism. 15. Uncontrollable hypertension, with systolic blood pressure>150mm Hg or diastolic blood pressure>100 mmHg after optimal medical treatment; History of hypertensive crisis or hypertensive encephalopathy. 16. Symptomatic congestive heart failure (New York Heart Association classification II-IV) or left ventricular ejection fraction (EF) value on echocardiography450 msec for males or 470 msec for females. 17. Severe bleeding tendency or coagulation dysfunction, or undergoing thrombolytic therapy. Currently in use or recently used (within 10 days prior to the first treatment in the study) aspirin (>325 mg/day) or anticoagulant drugs such as warfarin that require monitoring of INR, such as dipyridamole, thiaclopidine, clopidogrel, and cilostazol for treatment. 18. Within 6 months prior to the first treatment, there is a history of gastrointestinal perforation and/or fistula, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive intestinal resection (partial or extensive intestinal resection with conc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;DCR;OS;safety; | — |
Countries
China
Contacts
Public ContactMingzhi Hao
Fujian Cancer Hospital
Outcome results
None listed