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NCT Number: NCT05954897

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older.
  • 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.
  • Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
  • 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.
  • No prior treatment for HCC.
  • At least one measurable target lesion according to modified Response Evaluation Criteria 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 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

  • 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 effusion or pericardial effusion;
  • Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy;
  • Other reasons were judged by the investigator to be unable to enroll.

Treatment and study plan

Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC

Drug

RALOX Regimen of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Tislelizumab

Primary outcomes

  1. Objective Response Rate

    Time frame: After the first HAIC treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable,through study completion, an average of 12 months

    The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR) under mRECIST criteria

Secondary outcomes

  1. Progression-free survival

    Time frame: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

    The date from the date of admission to the date of the first progression of disease or death of any cause.

  2. Overall survival

    Time frame: Through study completion, up to 24 months

    The date from the date of admission to the date of death of any cause

  3. Disease control rate

    Time frame: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

    The percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy

  4. Adverse Events

    Time frame: Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).

    Categorized according to NCI Common Toxicity Criteria version 5.0. Summarized in terms of type, severity (grade 1-5), and dose level in tabular format.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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