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

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

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years or older.
  2. 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.
  3. Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) stagingsystem.
  4. 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.
  5. No prior treatment for HCC.
  6. At least one measurable target lesion according to modified Response EvaluationCriteria 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 timesthe upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upperlimit of normal.

Exclusion

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 effusionor pericardial effusion;
  6. Active bleeding or coagulation abnormalities, bleeding tendency or receivingthrombolytic, anticoagulant or antiplatelet therapy;
  7. 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
    China

    Active - Recruiting

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