TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma

Last updated: December 13, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Cancer

Digestive System Neoplasms

Liver Disorders

Treatment

TACE

PD-1 Inhibitors

Lenvatinib

Clinical Study ID

NCT06740370
Liver Projiect 14
  • Ages 18-75
  • All Genders

Study Summary

Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. diagnosis of primary HCC, confirmed histologically or clinically according to thecriteria of the American Association for the Study of Liver Diseases;

  2. presence of hemostasis in the enhanced CT scan;

  3. integrity of the tumor is disrupted and there is hematoma around the liver;

  4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;

  5. transarterial artery chemoembolization (TACE) as local therapy;

  6. classified as Child-Pugh class A or B and having an Eastern Cooperative OncologyGroup (ECOG) performance status of 0 or 2;

  7. no history of other malignancies.

  8. life expectancy more than 3 months;

  9. agreed to participated in this clinical trial;

  10. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Exclusion

Exclusion Criteria:

  1. recurrent HCC;

  2. non-ruptured HCC;

  3. Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;

  4. age < 18 years or > 75 years;

  5. HCC with more than five metastases;

  6. History of hepatic encephalopathy and gastrointestinal bleeding

  7. life expectancy less than 3 months.

Study Design

Total Participants: 32
Treatment Group(s): 3
Primary Treatment: TACE
Phase:
Study Start date:
December 13, 2024
Estimated Completion Date:
August 30, 2026

Study Description

Spontaneous rupture of HCC is a life-threatening complication. HCC rupture is considerably higher in China. The tumor size in ruptured HCC is significantly greater than that in non-ruptured HCC. In the acute phase, hemostasis is the first concern and then tumor treatment is secondary. TACE can effectively induce hemostasis. Conservative treatment is usually system therapy for unresectable ruptured HCC. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of TACE combined lenvatinib and PD-1 inhibitor for unresectable ruptured HCC. This study focuses on the efficacy of TACE combined with lenvatinib and PD-1 inhibitor as first-line therapy.

Connect with a study center

  • Qunfang Zhou

    Beijing, None Selected 100853
    China

    Active - Recruiting

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