RecruitingHepatocellular Carcinoma
Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma
Sponsor: Hunan Cancer Hospital
You may qualify if…
- ✓ 1. The written informed consent form should be signed before a subject participates in the trial；
- ✓ 2. Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by the American Association for the Study of Liver Diseases (AASLD)；
- ✓ 3. According to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 edition), eligible for China liver cancer staging (CNLC) Stage IIIa and is not suitable for radical treatment, such as resection, ablation, or liver transplantation. Suitable for HAIC surgery and chemotherapy drugs prescribed in advance by the research center, without any contraindications to HAIC surgery and chemotherapy drugs；
- ✓ 4. Child-Pugh A or B；
- ✓ 5. at least 1 measurable lesion according to RECIST v1.1；
- ✓ 6. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1；
- ✓ 7. Adequate organ and marrow function, as defined below； 1) Absolute neutrophil count (ANC) ≥1.5x109/L without granulocyte colony-stimulating factor in the last 14 days； 2) Platelets ≥75×109/L without transfusion in the last 14 days； 3) Hemoglobin ≥8.5 g/dL without transfusion or erythropoietin use in the last 14 days； 4) Serum total bilirubin (TBL) ≤2 × ULN； 5) AST and ALT ≤5× ULN； 6) Serum creatinine ≤1.5 × upper limit of normal (ULN)； Urine protein ≤(++) , or 24-hour urine protein quantification less than 1 g； 7) Good coagulation, defined as the international normalized ratio (INR) ≤ 2， or activated partial prothrombin time (PT) ≤ 1.5 times ULN；
- ✓ 8. a woman of childbearing potential (WOCBP) who is sexually active with a nonsterilized male partner must have a negative pregnancy test at the Screening visit (within 3 days before the first dose of the investigational product \[Cycle 1 Day 1\]). If a negative urine pregnancy test result cannot be confirmed, a blood pregnancy test will be requested. Females not of childbearing age were defined as being at least 1 year postmenopausal or having undergone surgical sterilization or hysterectomy；
You may not qualify if…
- ✕ 1. Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology;
- ✕ 2. Recurrence of previous hepatocellular carcinoma；
- ✕ 3. Autoimmune hepatitis (requires liver puncture)
- ✕ 4. Have a history of hepatic encephalopathy or liver transplantation;
- ✕ 5. Diffuse liver cancer;
- ✕ 6. Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage;
- ✕ 7. History of kidney disease or nephrotic syndrome;
- ✕ 8. Presence of bleeding events from esophageal or gastric varices caused by portal hypertension within the past 6 months. Presence of known severe (G3) varicose veins in endoscopy within 3 months before the first dose. Evidence of portal hypertension (including the finding of splenomegaly in imaging studies) with a high risk of bleeding assessed by the investigator;
Source: ClinicalTrials.gov · NCT06406634 · last updated 2024-05-09