This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined conversion therapy strategy for patients with initially unresectable hepatocellular carcinoma (HCC).The primary objective is to assess the outcomes of intention-to-treat (ITT) patients who received multidisciplinary conversion therapy. This therapy combines locoregional treatments (LRT, such as TACE or radiotherapy) with systemic therapy (anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors) with the goal of down-staging tumors to allow for subsequent curative resection.
The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients with initially unresectable HCC who received the combined conversion therapy between January 2018 and December 2024. A control group of about 200 patients with initially resectable HCC who underwent direct radical surgery during the same period will be used for comparison. Data will be collected retrospectively from hospital electronic medical records and the HCC clinical database, with follow-up until December 2025.
Aged 16 years or older.
Clinical and/or pathological diagnosis of hepatocellular carcinoma (HCC). China Liver Cancer (CNLC) stage I, II, or IIIA.
Assessed by a multidisciplinary team (MDT) as having initially unresectable HCC.
Presence of extrahepatic metastasis.
Presence of Cheng's type IV portal vein tumor thrombus (PVTT).
Presence of Cheng's type II or III inferior vena cava tumor thrombus (IVCTT).
This retrospective single-center cohort study includes 300 HCC patients (2018-2024), divided by initial resectability: Initially Unresectable HCC Cohort（N=100）: Received multimodal conversion therapy (LRT + anti-VEGF/TKIs + ICIs) aiming to downstage tumors for resection. Initially Resectable HCC Cohort（N=200）: Underwent direct radical resection without prior conversion therapy. Patients were aged ≥16 with CNLC stage I-IIIA HCC. Exclusions: extrahepatic metastasis or Cheng's type IV PVTT/type II-III IVCTT. Data are collected retrospectively from EMR and an HCC database.
Case-control
Retrospective
Locoregional Therapy (LRT) + Systemic Drug Therapy
Combination productTreatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.
Conversion Rate
Proportion of ITT patients with initially unresectable HCC successfully down-staged to resectability after conversion therapy (per MDT reassessment).
1-, 2-, and 3-year OS in ITT Population
Proportion of patients in the ITT population alive at 1, 2, and 3 years after initiation of conversion therapy (Kaplan-Meier method).
Resection Rate After Conversion
Proportion of patients who successfully undergo curative resection after down-staging.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
