Treatment for ruptured liver cancer using TACE, Lenvatinib, and PD-1 inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness and safety of combining transcatheter arterial chemoembolization (TACE) with Lenvatinib and PD-1 inhibitors for patients with unresectable ruptured hepatocellular carcinoma (HCC). The approach aims to first achieve hemostasis in patients experiencing life-threatening complications due to tumor rupture, followed by systemic therapy to inhibit tumor growth. The study is multicenter and single-arm, focusing on patients classified as Child-Pugh class A or B with specific eligibility criteria. The goal is to improve prognosis and treatment outcomes for this severe condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria 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 Oncology Group (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 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.

Where it's running

• Qunfang Zhou
  Beijing, None Selected, China Recruiting

Study contacts

• Study coordinator: Qunfang Zhou, MD
• Email: zhouqun988509@163.com
• Phone: 86 19868000115

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ablation combined with lenvatinib and PD-1 inhibitor for advanced liver cancer with limited metastases

  This study is testing if combining a targeted treatment with a special type of therapy can help people with advanced liver cancer that has spread a little, to see if it improves their chances of living longer.

  Recruiting Sun Yat-sen University · Beijing, None Selected · NCT06550921

• Combining chemotherapy and targeted therapy for advanced liver cancer

  This study is testing whether combining a specific type of chemotherapy with two targeted therapies can help people with advanced liver cancer feel better and improve their treatment results.

  Recruiting Sun Yat-sen University · Beijing, Beijing Municipality · NCT06333561

• Combining Lenvatinib, Tislelizumab, and TACE for Liver Cancer Treatment

  This study is testing a new combination treatment for liver cancer to see if it can help patients at high risk of their cancer coming back after surgery.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT05920863

• BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer

  This study tests whether the investigational drug BGB-B2033 can help people with advanced hepatocellular carcinoma when given after prior PD-1/PD-L1 therapy, compared with the standard medicines sorafenib or lenvatinib.

  Recruiting at 2 sites Phase 3 BeOne Medicines · South Brisbane, Queensland and 1 other locations · NCT07836530

• Durvalumab + Tremelimumab with or without Lenvatinib for unresectable liver cancer

  This trial tests whether adding lenvatinib to the STRIDE regimen (durvalumab plus tremelimumab) helps people with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

  Recruiting at 13 sites Phase 2 Canadian Cancer Trials Group · Calgary, Alberta and 12 other locations · NCT06880523

• Combining TIPS with Lenvatinib and PD-1 inhibitors for advanced liver cancer with portal vein tumor thrombus

  This study is testing if combining a special procedure with two cancer treatments can help people with advanced liver cancer and a serious blood clot in the portal vein feel better and have better results.

  Recruiting Sun Yat-sen University · Beijing, None Selected · NCT06622031

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.