A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Participants must meet all of the following criteria to be included:

• Participants must voluntarily agree to participate in the study and provide written informed consent, be compliant, and agree to follow-up.

• Participants must be between 18 and 80 years old, regardless of gender, at the time of signing the informed consent form.

• Participants must be diagnosed with hepatocellular carcinoma by imaging (according to AASLD criteria or the 2022 National Health Commission Guidelines for the Diagnosis and Treatment of Liver Cancer) or histological or cytological examination.

• Patients with advanced liver cancer: patients who are in BCLC stage C or B and are eligible for TACE treatment.

• Participants must not have received systemic treatment.

• There must be at least one measurable lesion (according to RECIST 1.1 criteria, the measurable lesion must have a spiral CT scan long diameter ≥10 mm or an enlarged lymph node short diameter ≥15 mm).

• ECOG performance status must be 0-1 point within 1 week before enrollment.

• Child-Pugh liver function grade: Class A (5-6 points).

• Expected survival time ≥3 months.

• Active hepatitis B or C patients must receive relevant antiviral treatment, with HBV-DNA \<2500 IU/mL (\<105 copies/mL) and have received antiviral treatment for at least 14 days before participating in the study. HCV RNA-positive patients must be treated according to local standard treatment guidelines and have liver function increased no more than Grade 1 in CTCAE during treatment.

• Hematological and organ function must be adequate, based on laboratory test results obtained within 14 days before starting the study treatment, unless otherwise specified:

⁃ Complete blood count: (not transfused, not treated with G-CSF or drugs for correction) white blood cell count ≥ 3.0 x 109/L, Hb ≥ 90 g/L, neutrophil count ≥ 1.5 × 109/L, and platelet count ≥ 60 × 109/L.

• Biochemical tests: (not given albumin in the last 14 days)

• Appropriate liver function: ALB ≥ 29 g/L, ALP, ALT, and AST \<5 × ULN, TBIL ≤ 3 × ULN, and PT prolongation time no more than 6s of ULN

• Appropriate renal function: Creatinine ≤ 1.5 × ULN, or creatinine clearance (CCr) \>50 mL/min (using the Cockcroft-Gault formula):

⁃ Female: CrCl = ((140 - age) × body weight (kg) × 0.85) / 72 × serum creatinine (mg/dL) Male: CrCl = ((140 - age) × body weight (kg) × 1.00) / 72 × serum creatinine (mg/dL)

⁃ • Women of childbearing potential: must agree to abstain from sexual activity or use a contraceptive method with a failure rate of less than 1% for at least 6 months during the treatment period and after the last dose.

⁃ If a female patient has menstruated and has not yet reached postmenopausal status (no menstrual periods for ≥12 months continuously, and no other causes for menopause except surgical sterilization), and has not undergone sterilization surgery (removal of the ovaries and/or uterus), she is considered to be of childbearing potential.

Locations
Other Locations
China
Nan Zhang
RECRUITING
Beijing
Contact Information
Primary
Nan Zhang, M.D.
zhnan123@hotmail.com
+86 15600802833
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2024-11-15
Participants
Target number of participants: 60
Treatments
Experimental: Levatinib plus Tislelizumab
Native-treated aHCC Patients were administered with Levatinib plus Tislelizumab
Experimental: Levatinib plus Lenvatinib with Transarterial Chemoembolization(TACE)
Native-treated aHCC Patients were administered with Levatinib plus Tislelizumab with Transarterial Chemoembolization(TACE)
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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