Not Yet RecruitingPhase 2

A Study to Evaluate Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses

30 participantsStarted 2023-08-01

Plain-language summary

The purpose of this study is to investigate the efficacy and safety of Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Signed written informed consent before screening;
✓. Age ≤ 18 years old ≤75 years old for both men and women;
✓. ECOG score 0-1;
✓. A clinical or pathological diagnosis of hepatocellular carcinoma should meet one of the following criteria: ① A histological or cytological diagnosis of hepatocellular carcinoma, except for fibrolamellar, sarcomatoid or mixed cholangiocarcinoma; ② According to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition), the patient was clinically diagnosed with HCC;
✓. Hepatitis B virus surface antigen (HBsAg) positive and hepatitis B virus (HBV) DNA\<2000IU/ml or 104 copies /ml; Or hepatitis B virus core antibody (HBcAb) positive, HBsAg negative, and highly sensitive HBV DNA\<2000IU/ml or 104 copies /ml;
✓. have not previously received any systemic therapy for HCC (mainly including systemic chemotherapy, antivascular therapy, molecular targeted therapy, immunotherapy targeting any other antibodies or drugs that act on T-cell co-stimulation or immune checkpoint pathways, Including but not limited to anti-PD-1, anti-PD-L1 /L2, anti-CD137 or anti-ctLA-4 antibodies), and disease progression 6 months after the end of postoperative adjuvant chemotherapy were allowed to be enrolled;
✓. Chinese clinical stage of liver cancer (CNLC) Ⅲb or CNLC Ⅱb-Ⅲa which is not suitable for surgery and/or local treatment;
✓. Child-Pugh rating for liver function: Grade A and good Grade B (≤7 points), and no history of hepatic encephalopathy;

Exclusion criteria

✕. Liver surgery and/or local treatment for HCC, except palliative radiotherapy for bone metastases to relieve pain, had been performed within 4 weeks prior to initial study drug therapy;
✕. Subjects (except hair loss and fatigue) who have not recovered from any toxicity and/or complications of local therapy (including interventional therapy, radio frequency therapy, etc.), previous chemotherapy, surgery, radiotherapy, that is, have not fallen to ≤ Grade 1 (NCI CTCAE version 5.0);
✕. Have received anti-tumor drug therapy in the past (including but not limited to traditional Chinese medicine preparations with anti-tumor indications);
✕. With moderate or severe ascites or ascites requiring drainage, or with pleural or pericardial effusion requiring drainage and/or symptoms of shortness of breath;
✕. with known active central nervous system metastases (CNS) and/or cancerous meningitis;
✕. With other malignancies (other than cured cervical carcinoma in situ, non-melanoma skin cancer or other tumors/cancers that have been treated radically and have shown no signs of disease for at least 5 years);

What they're measuring

Objective response rate (ORR)

Timeframe: 12 months

Trial details

NCT IDNCT05897138

SponsorFujian Cancer Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-06-01

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