Last updated: July 12, 2023
Sponsor: Guangdong Provincial People's Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Digestive System Neoplasms
Liver Cancer
Hepatic Fibrosis
Treatment
Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC
Clinical Study ID
NCT05954897
KY2023-124-02
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 years or older.
- HCC was diagnosed according to the Criteria for Diagnosis and Treatment of PrimaryLiver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria.
- Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) stagingsystem.
- A dominant mass in theliver with or without extrahepatic oligometastasis, which wasdefined as up to three metastatic lesions in up to two organs with the largestdiameter of≤3 cm.
- No prior treatment for HCC.
- At least one measurable target lesion according to modified Response EvaluationCriteria in Solid Tumors (mRECIST).
- Performance status (PS) ECOG score ≤1.
- Child-Pugh score ≤7.
- Subjects voluntarily participate in this study, and sign the informed consent form,cooperate with the follow-up
- Adequate organ function, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 ^ 9/L; PLT ≥ 75 x 10 ^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AST and ALT ≤ 3 timesthe upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upperlimit of normal.
Exclusion
Exclusion Criteria:
- Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC,hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type;
- Previous liver transplantation;
- History of other malignancies;
- Previous history of severe mental illness;
- Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusionor pericardial effusion;
- Active bleeding or coagulation abnormalities, bleeding tendency or receivingthrombolytic, anticoagulant or antiplatelet therapy;
- Other reasons were judged by the investigator to be unable to enroll.
Study Design
Total Participants: 29
Treatment Group(s): 1
Primary Treatment: Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC
Phase: 2
Study Start date:
September 01, 2023
Estimated Completion Date:
January 01, 2027
Connect with a study center
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
ChinaActive - Recruiting
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