Prognosis model for advanced liver cancer treatment
Personalized Model of Prognosis Stratification for Patients with Advanced HCC Receiving TACE Combined with PD-1/PD-L1 Inhibitors Plus Molecular Target Therapies
This study is trying to find out which patients with advanced liver cancer will benefit the most from a combination of a specific treatment and immune therapy to help doctors make better treatment choices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 950 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhongda Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, bevacizumab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06607120 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a personalized prognosis stratification model for patients with advanced-stage hepatocellular carcinoma (HCC) undergoing transarterial chemoembolization (TACE) combined with immune checkpoint inhibitors and molecular target therapies. It seeks to identify which patients are most likely to benefit from this combination therapy, as previous studies have shown improved outcomes with these treatments. By analyzing real-world data, the study hopes to enhance treatment selection and inform clinical practice for HCC management.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with advanced-stage HCC who have not previously received systemic therapy and are undergoing TACE in combination with immune checkpoint inhibitors.
Not a fit: Patients with other liver cancer subtypes, such as cholangiocarcinoma or fibrolamellar carcinoma, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with advanced HCC, improving their survival rates and quality of life.
How similar studies have performed: Previous studies have indicated that combining TACE with immune checkpoint inhibitors and molecular therapies can improve patient outcomes, suggesting this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion; 3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy); 4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval; 5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months); 6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment; 7. Has repeated measurable intrahepatic lesions; Exclusion Criteria: 1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. Unable to meet criteria of combination timeframe described above; 3. Child-Pugh C or PS\>2 or Severe hepatic encephalopathy
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Gao- Teng, M.D — Zhongda hospital, Southeast university, Nanjing, China
- Study coordinator: Gao-Jun Teng, M.D
- Email: gjteng@vip.sina.com
- Phone: +86-02583272121
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.