Combining lenvatinib and tislelizumab with RALOX for advanced liver cancer

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma: a Phase II, Single-arm, Prospective Study

This study is testing a new combination of treatments for advanced liver cancer to see if it works better than current options for patients with stage C hepatocellular carcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Drugs / interventions: tislelizumab, lenvatinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05954897 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination treatment involving lenvatinib, tislelizumab, and the RALOX regimen administered via hepatic arterial infusion chemotherapy (HAIC) for patients with advanced hepatocellular carcinoma (HCC). The study focuses on individuals diagnosed with stage C HCC, aiming to determine how well this combination therapy works compared to existing treatments. Participants will be monitored for treatment response and safety outcomes throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with stage C hepatocellular carcinoma who have not received prior treatment.

Not a fit: Patients with prior treatments for HCC or those with more advanced liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced hepatocellular carcinoma.

How similar studies have performed: While this specific combination is novel, similar approaches using targeted therapies and immunotherapies have shown promise in treating hepatocellular carcinoma.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Xiaoming Chen — 106 Second Zhongshan Road, Guangzhou, Guangdong
• Study coordinator: Feng Shi

Conditions Hepatocellular Carcinoma