HCC
Conditions
Interventions
TACE-HAIC combined with Treprozumab and Bevacizumab (TH-TB) group:TACE-HAIC combined with Treprozumab and Bevacizumab
TACE plus Treprolizumab and Bevacizumab (T-TB):TACE plus Treprolizumab and Bevacizumab (T-TB)
HAIC combined with Treprozumab and Bevacizumab (H-TB) group:HAIC combined with Treprozumab and Bevacizumab
Sponsors
Sun Yat-sen University Cancer Center (Sun Yat-sen University Cancer Hospital, Sun Yat-sen University Cancer Institute)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with hepatocellular carcinoma (HCC) according to the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)" issued by the National Health Commission of China, and the 2018 EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma; or histopathologically or cytologically confirmed HCC, with no prior transplantation, ablation, cryotherapy, immunotherapy, or targeted therapy before enrollment; 2. Tumor meeting all the following conditions: initially unresectable HCC, BCLC stage B or C (if with portal vein tumor thrombus, limited to VP 1–3 type, without distant metastasis), and the maximum tumor diameter >3 cm; 3. At least one evaluable intrahepatic lesion according to RECIST v1.1 criteria; 4. ECOG performance status score of 0; 5. Life expectancy of at least 3 months; 6. Age >= 18 years; 7. Child-Pugh score 5–7; 8. Baseline laboratory tests meeting the following criteria: (1) Absolute neutrophil count >= 1.5×10^9/L; (2) White blood cell count >= 3.0×10^9/L; (3) Platelet count >= 75×10^9/L; (4) Hemoglobin >= 80 g/L; (5) Serum ALT and AST = 30 g/L; (9) Total bilirubin <= 1.5 × ULN; 9. Signed and dated informed consent form. 10. Good patient compliance.
Exclusion criteria
Exclusion criteria: 1. Massive ascites, or a history of hepatic encephalopathy, or a history of upper gastrointestinal bleeding within the past 3 months; 2. Presence of one or more of the following: esophageal or gastric variceal bleeding events due to portal hypertension within the past 3 months; severe (G3) varices still present after endoscopic band ligation or sclerotherapy prior to first dose; portal hypertension indicated by imaging or endoscopy, with a high risk of bleeding as assessed by the investigator; 3. Poor general condition or cachexia; 4. Refusal to receive PD-1 inhibitor toripalimab and targeted therapy with bevacizumab; 5. Any of the following within 12 months before study start: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; ongoing arrhythmias >= Grade 2 per NCI-CTCAE criteria, or QTc interval prolongation (male >450 ms, female >470 ms); 6. Renal insufficiency requiring peritoneal dialysis or hemodialysis; 7. Severe dysfunction of other vital organs; 8. Previously diagnosed with a second primary malignancy; 9. Known or new evidence of brain or leptomeningeal involvement; 10. Hemophilia or bleeding diathesis, or currently receiving therapeutic doses of coumarin derivatives or other anticoagulant therapy; 11. Pregnant or breastfeeding women; all female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment; 12. History of organ transplantation; 13. Known HIV infection; 14. Allergy to chemotherapy drugs; 15. Other severe acute or chronic physical or psychiatric conditions, or laboratory abnormalities that may increase the risk associated with study participation, or may interfere with the interpretation of study results, or are considered by the investigator to make the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Live (OS);Objective response rate;Conversion rate to resection; | — |
Countries
China
Contacts
Public ContactYuan Yunfei
Sun Yat-sen University Cancer Center (Sun Yat-sen University Cancer Hospital, Sun Yat-sen University Cancer Institute)
Outcome results
None listed