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Clinical Trials/NCT07639294
NCT07639294CompletedNot Applicable

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

Tongji Hospital1 site in 1 country715 target enrollmentStarted: June 1, 2018Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
715
Locations
1

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cheng Qi

Deputy Director of Hepatobiliary and Pancreatic Surgery Department

Tongji Hospital

Study Sites (1)

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