Actively Recruiting
Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma
Led by Guangdong Provincial People's Hospital · Updated on 2023-07-20
29
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.
CONDITIONS
Official Title
Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Diagnosed with hepatocellular carcinoma according to the 2022 Criteria for Diagnosis and Treatment of Primary Liver Cancer and AASLD criteria
- Classified as stage C by the Barcelona Clinic Liver Cancer (BCLC) staging system
- Presence of a dominant mass in the liver with or without up to three extrahepatic metastatic lesions in up to two organs, each less than or equal to 3 cm
- No previous treatment for hepatocellular carcinoma
- At least one measurable target lesion by modified Response Evaluation Criteria in Solid Tumors (mRECIST)
- Performance status (ECOG) score of 0 or 1
- Child-Pugh liver function score of 7 or less
- Voluntary participation with signed informed consent and willingness to cooperate with follow-up
- Adequate organ function including hemoglobin ≥ 90 g/dL; neutrophils ≥ 1.5 x 10^9/L; platelets ≥ 75 x 10^9/L; albumin ≥ 2.8 g/dL; total bilirubin ≤ twice the upper limit of normal; AST and ALT ≤ 3 times the upper limit of normal; creatinine ≤ 1.5 times the upper limit of normal; APTT ≤ 1.5 times the upper limit of normal
You will not qualify if you...
- Diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) type
- Previous liver transplantation
- History of other malignancies
- Previous history of severe mental illness
- Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion, or pericardial effusion
- Active bleeding or blood clotting abnormalities, bleeding tendency, or current use of thrombolytic, anticoagulant, or antiplatelet therapy
- Any other conditions judged by the investigator to prevent enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
F
Feng Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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