The Application of Locoregional Therapy Combined With Systemic Therapy in the Perioperative Period of Huge Hepatocellular Carcinoma: A Retrospective Cohort Study

NCT07639294 | Completed

• 1 other identifier: Huge-HCC-retro001
• Study Type: observational
• Target: 715
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective cohort study collected data of patients with huge hepatocellular carcinoma (HCC) treated between June 1, 2018, and December 31, 2023, through the hospital information system. Patients were divided into a neoadjuvant conversion-first cohort and an upfront surgery cohort based on whether they received preoperative locoregional therapy combined with targeted and immunotherapy. The conversion-first cohort was further stratified into a conversion surgery group and a non-surgery group according to whether curative-intent hepatectomy was ultimately achieved. The upfront surgery cohort was divided into a postoperative adjuvant therapy group and a postoperative surveillance group based on whether adjuvant immunotherapy was administered after surgery. The primary objective was to analyze differences in overall survival (OS) and progression-free survival (PFS) among the four groups and to evaluate the impact of neoadjuvant conversion therapy on the safety of hepatectomy.

Conditions

Huge Hepatocellular Carcinoma (HCC) (>10cm)

Outcome Measures

Primary Outcomes (1)

• overall survival

  From date of treatment until the date of death from any cause, assessed up to 66 months

Secondary Outcomes (2)

• Progression-free survival

  from the date of the first treatment to the date of tumor progression, assessed up to 66 months

• Textbook Outcome in Liver Surgery

  Within 90 days following surgery

Study Arms (4)

upfront surgery with active surveillance

Procedure: hepatectomy without immune checkpoint inhibitors-based adjuvant therapy

surgery with adjuvant treatment

Procedure: hepatectomy with immune checkpoint inhibitors-based adjuvant therapy

neoadjuvant conversion surgery group

Procedure: neoadjuvant conversion therapy followed by surgery

non-surgery

Drug: Non-surgery

Interventions

Non-surgery DRUG

Patients who received the neoadjuvant conversion therapy but eventually not underwent surgery

non-surgery

neoadjuvant conversion therapy followed by surgery PROCEDURE

Patients were treated preoperatively with a combination of immune checkpoint inhibitors (ICIs), targeted drugs, and locoregional interventions, such as transarterial chemoembolization (TACE) and/or and/or hepatic artery infusion chemotherapy (HAIC).ICIs included pembrolizumab, atezolizumab, tislelizumab, sintilimab, camrelizumab, toripalimab, and durvalumab. Targeted drugs included lenvatinib, bevacizumab, donafenib, sorafenib, regorafenib, and apatinib. The choice of different locoregional therapies and systemic therapy agents for HCC was made by weighing the patient's wishes, cost considerations, and multidisciplinary team (MDT) discussions. ICIs and targeted drugs were used until the disease progressed or an intolerable adverse event occurred.

neoadjuvant conversion surgery group

hepatectomy without immune checkpoint inhibitors-based adjuvant therapy PROCEDURE

All procedures were performed by senior hepato-pancreato-biliary surgeons who completed over 100 hepatectomy procedures annually. Intraoperative ultrasound was routinely performed to identify any potential tumor nodules that were not detected before surgery and to help rule out parenchymal transection plane. The resection margin should extend 1 cm beyond the tumor edge whenever possible. Pringle's maneuver and the low central venous pressure technique were performed routinely.For difficult hepatectomy, the anterior approach (parenchymal transection without prior mobilization of the liver) was applied and the hepatic pedicle and the inferior vena cava below the liver were clamped simultaneously for better hepatic vascular inflow and outflow control. Liver parenchymal transection was performed by an ultrasonic scalpel. After surgery, all patients were followed up according to the visit schedules and contents recommended by the Chinese guidelines for HCC.

upfront surgery with active surveillance

hepatectomy with immune checkpoint inhibitors-based adjuvant therapy PROCEDURE

After surgery, patients who agreed to receive postoperative adjuvant therapy began to undergo immunotherapy when recovered well from the surgery and alanine aminotransferase and aspartate aminotransferase were both less than 80 U/L and total bilirubin was less than 2 mg/dL. Immune checkpoint inhibitors (ICIs) included pembrolizumab, atezolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab. The specific agents of ICIs were determined by the patients' wishes and consultation with their attending physicians. ICIs were injection once every 3 weeks for 12 months and would be terminated when disease progressed or intolerable toxicity occurred. Meanwhile, some patients underwent adjuvant transarterial chemoembolization (TACE) and/or target therapy.

surgery with adjuvant treatment

Eligibility Criteria

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

Study Population

Patients who were identified as potentially convertible huge HCC and underwent treatment between June 2018 and December 2023

You may qualify if:

• pathologically or clinically diagnosed HCC with a tumor diameter exceeding 10 cm on initial computed tomography (CT) or magnetic resonance imaging (MRI);
• ≤ 3 tumor nodules;
• portal vein tumor thrombus (PVTT) that had not invaded the main portal vein or the contralateral branch of portal vein (Vp0-3 PVTT);
• absence of extrahepatic metastasis; (5) Child-Pugh score of 5-7 and Eastern Cooperative Oncology Group performance status of 0-1.

You may not qualify if:

• mixed tumors with HCC and cholangiocarcinoma;
• recurrent HCC;
• tumor thrombus invading the inferior vena cava;
• combined with any malignancy other than HCC;
• incomplete clinical or follow-up data.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Hepatobiliary and Pancreatic Surgery Department

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CN (1)