NCT07581769Active, not recruiting
Radiomics Subtyping to Guide Surgery vs. Maintenance Therapy After HCC Downstaging
A Retrospective Radiomics-Based Subtyping Study to Guide Post-Downstaging Treatment Selection in Patients With Unresectable Hepatocellular Carcinoma Following TACE Plus Lenvatinib and Anti PD-1
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
The goal of this observational study is to learn about the long-term treatment outcomes for patients with initially unresectable hepatocellular carcinoma (HCC) who achieve successful downstaging with the combination therapy of TACE, lenvatinib, and a PD-1 inhibitor. The main questions it aims to answer are: Can distinct disease subtypes be identified in successfully downstaged patients using radiomics and clinical data? Do these different subtypes show significant differences in long-term outcomes, such as recurrence-free survival and overall survival, after undergoing either curative-intent surgical resection or continuing maintenance therapy? Based on the identified subtypes, can the investigators objectively determine which patients are more suitable for surgical resection and which patients may benefit more from continued maintenance therapy after successful downstaging? The study will include patients who have already undergone the combination therapy as part of their regular medical care, successfully achieved tumor downstaging (making the tumor technically resectable), and subsequently received either surgical resection or continued maintenance treatment. Researchers will retrospectively analyze their existing clinical and imaging data to compare long-term outcomes between these two treatment paths based on their identified disease subtype.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 6 May 2026
- Start date
- 1 Jan 2018
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07581769
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Jan 2018 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with unclear diagnoses or those with concurrent other malignancies.
- For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively.
- For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors.
- Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy.
Other illness
- Patients with severe infections, such as respiratory, biliary tract, or abdominal infections.
- Patients with severe underlying diseases, particularly immune-related disorders.
Who the study is looking for
- Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria;
- Barcelona Clinic Liver Cancer (BCLC) stage B or C, assessed as unresectable by surgical evaluation; Underwent treatment with TACE combined with lenvatinib and a PD-1 inhibitor, after which the tumor was re-evaluated and deemed resectable by surgical assessment;
- Following the achievement of surgical resectability criteria, patients subsequently underwent either R0 surgical resection or continued treatment with TACE combined with lenvatinib and a PD-1 inhibitor;
- Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment;
- Performance status (PS) score of 0 or 1.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiiated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.