Treatment for ruptured liver cancer using TACE, Lenvatinib, and PD-1 inhibitors
TACE Combined With Lenvatinib and PD-1 Inhibitor for Spontaneous Rupture of Hepatocellular Carcinoma: a Prospective Multicenter Study
This study is testing a new treatment that combines a special type of chemotherapy with Lenvatinib and PD-1 inhibitors to see if it can help patients with serious liver cancer that has ruptured.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Lenvatinib |
| Locations | 1 site (Beijing, None Selected) |
| Trial ID | NCT06740370 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with primary ruptured HCC who meet specific clinical and laboratory criteria.
Not a fit: Patients with recurrent or non-ruptured HCC will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with ruptured hepatocellular carcinoma.
How similar studies have performed: While the combination of TACE with systemic therapies is explored in other studies, this specific approach for ruptured HCC is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, None Selected
- Qunfang Zhou — Beijing, None Selected, China (Recruiting)
Study contacts
- Study coordinator: Qunfang Zhou, MD
- Email: zhouqun988509@163.com
- Phone: 86 19868000115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.