Downstaging, Hepatocellular Carcinoma (HCC), Lenvatinib, Liver Resection, PD1 Antibody, Transarterial Chemoembolization
Conditions
Keywords
Downstaging, Hepatocellular carcinoma, Liver resection, Lenvatinib, PD1 antibody, Transarterial chemoembolization
Brief summary
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.
Interventions
PROCEDURELiver resection
This intervention consists of curative-intent surgical resection of hepatocellular carcinoma (HCC) performed after successful downstaging achieved through prior TACE combined with lenvatinib and PD-1 inhibitor therapy. The procedure aims to remove all visible and radiologically responsive tumor tissue to achieve a pathologically confirmed R0 resection margin.
PROCEDURETACE plus Lenvatinib and PD1 inhibiter
This intervention describes the non-surgical maintenance therapy for patients in the Maintenance Group after successful downstaging. It consists of continuing the same doses of lenvatinib and PD-1 inhibitor that were administered during the downstaging phase, combined with on-demand TACE performed only upon imaging or biomarker evidence of intrahepatic progression.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria; 2. 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; 3. 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; 4. Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment; 5. Performance status (PS) score of 0 or 1.
Exclusion criteria
1. Patients with unclear diagnoses or those with concurrent other malignancies. 2. For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively. 3. For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors. 4. Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy. 5. Patients with severe infections, such as respiratory, biliary tract, or abdominal infections. 6. Patients with severe underlying diseases, particularly immune-related disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence free survival | From date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months | Time interval from date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months | Time interval from date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWenzhe Fan, Dr.
First Affiliated Hospital, Sun Yat-Sen University
PRINCIPAL_INVESTIGATORShunjun Fu, Dr.
Southern Medical University, China
Outcome results
None listed