Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC

Study type: Interventional

Funder types: Other

Identifiers

NCT05954897

KY2023-124-02

Details and patient eligibility

About

To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.

Enrollment: 29 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years or older.
2. HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria.
3. Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
4. A dominant mass in theliver with or without extrahepatic oligometastasis, which was defined as up to three metastatic lesions in up to two organs with the largest diameter of≤3 cm.
5. No prior treatment for HCC.
6. At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST).
7. Performance status (PS) ECOG score ≤1.
8. Child-Pugh score ≤7.
9. Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up
10. 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 times the upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upper limit of normal.

Exclusion criteria

1. Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type;
2. Previous liver transplantation;
3. History of other malignancies;
4. Previous history of severe mental illness;
5. Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;
6. Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy;
7. Other reasons were judged by the investigator to be unable to enroll.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Drug: Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC