A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Unresectable Hepatocellular Carcinoma
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ningbo Medical Center Lihuili Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Conversion Rate
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
Initially Unresectable HCC with Conversion Therapy
This cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as unresectable (due to surgical inoperability or oncological unresectability per multidisciplinary team evaluation) but intended for curative treatment. All patients in this cohort received multimodal conversion therapy between January 2018 and December 2024. The therapy aimed to downstage the tumor and primarily included a combination of locoregional therapies (LRT) (such as TACE, HAIC, or radiotherapy) and systemic drug therapy (including anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors). Patient data are collected retrospectively from electronic medical records and the HCC clinical database.
Intervention: Locoregional Therapy (LRT) + Systemic Drug Therapy (Combination Product)
Initially Resectable HCC
This cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as resectable and suitable for curative surgery per multidisciplinary team evaluation. All patients in this cohort underwent direct radical resection (curative-intent surgery) as the primary treatment between January 2018 and December 2024, without receiving prior locoregional or systemic conversion therapy. Patient data are collected retrospectively from electronic medical records and the HCC clinical database.
Outcomes
Primary Outcomes
Conversion Rate
Time Frame: From the start of conversion therapy until the completion of therapy (assessed up to 24 months).
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
Time Frame: Starting from conversion therapy, evaluate at 1, 2, and 3 years.
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
Time Frame: From the start of conversion therapy to the day of surgery (with a maximum evaluation period of 24 months).
Proportion of patients who successfully undergo curative resection after down-staging.
Secondary Outcomes
No secondary outcomes reported
Investigators
Caide Lu
Chief Physician
Ningbo Medical Center Lihuili Hospital