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

NCT07368023 | Not Yet Recruiting

• 1 other identifier: KY2025PJ484
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Hepatocellular Carcinoma Non-resectable

Outcome Measures

Primary Outcomes (3)

• Conversion Rate

  Proportion of ITT patients with initially unresectable HCC successfully down-staged to resectability after conversion therapy (per MDT reassessment).

  From the start of conversion therapy until the completion of therapy (assessed up to 24 months).

• 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).

  Starting from conversion therapy, evaluate at 1, 2, and 3 years.

• Resection Rate After Conversion

  Proportion of patients who successfully undergo curative resection after down-staging.

  From the start of conversion therapy to the day of surgery (with a maximum evaluation period of 24 months).

Study Arms (2)

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.

Combination Product: Locoregional Therapy (LRT) + Systemic Drug Therapy

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.

Interventions

Locoregional Therapy (LRT) + Systemic Drug Therapy COMBINATION_PRODUCT

Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.

Initially Unresectable HCC with Conversion Therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead

Study Sites (1)

Ningbo Medical Centre Lihuili Hospital

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Caide Lu, Professor

  Ningbo Medical Centre Lihuili Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caide Lu, Professor

CONTACT

+8613957800900; lucaide@nbu.edu.cn

Shuqi Mao, Professor

CONTACT

+8617855848257; mmmaoshuqi@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 26, 2026
• Study Start: January 25, 2026
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CN (1)