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RecruitingNCT06405321Updated Jan 14, 2026

Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma

An observational study in Hepatocellular Carcinoma, sponsored by Guangxi Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by Guangxi Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This multicenter retrospective study which included patients with hepatocellular carcinoma (HCC) who received conversion or neoadjuvant therapy to explore the best treatment options and the best benefit group.

Read the detailed description

More than 50% patients with initial hepatocellular carcinoma (HCC) are diagnosed as intermediate or advanced stage diease. Transarterial chemoembolization and systemic therapy are main treatments for these patients. With the rise of targeted drugs and immunotherapy, more and more patients with advanced HCC have access to curative treatment, thereby extending their overall survival time. In clinical practice, there are many combinations used to treat these patients. However, the safety and efficacy of conversion or neoadjuvant therapy in HCC patients remains controversial.

The aim of this project is to establish a multicentre database from Guangxi province, China, to include as many HCC patients receiving conversion or neoadjuvant therapy as possible. HCC patients who received conversion or neoadjuvant therapy as initial treatment, including hepatic artery infusion chemotherapy (HAIC), transcatheter arterial chemoembolization (TACE), tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), or radiotherapy were retrospectively enrolled. The purpose of this project is to explore the best beneficiaries of conversion or neoadjuvant therapy, the best treatment strategy, and the follow-up treatment options after successful conversion therapy. The ultimate objective is to provide evidence for the necessity and feasibility of conversion or neoadjuvant therapy for patients with HCC.

The data for this study were derived from the database of the regional registry platform entitled "Guangxi Liver Cancer Clinical Study Alliance (GUIDANCE)" sponsored by the Guangxi Anticancer Association Liver Cancer Committee. All of the included patients were not previously reported and were not enrolled in those industry-sponsored clinical trials.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • conversion therapy
  • neoadjuvant therapy
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with hepatocellular carcinoma who received conversion or neoadjuvant therapy as initial treatment would be included.

Inclusion criteria

  • Histologically or clinically confirmed diagnosis of HCC.
  • Patients who received conversion or neoadjuvant therapy as initial treatment, including hepatic artery infusion chemotherapy (HAIC), transcatheter arterial chemoembolization (TACE), tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), or radiotherapy.
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1.
  • With Child-Pugh 5\~7 scores.

Exclusion criteria

Exclusion Criteria:

  • Concurrent with other malignancies within 5 years.
  • Incomplete medical data.
  • Follow-up time less than 3 months.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Conversion or Neoadjuvant Therapy

    Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy.

    Drug: Conversion or neoadjuvant therapy.

Interventions

  • DrugConversion or neoadjuvant therapy.

    Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy.

05

What researchers measure

Primary outcomes

  1. Overall survival

    1 year overall survival

    Time frame: 1 year

Secondary outcomes

  1. progression-free survival

    1 year progression-free survival

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • Yang DL, Yan YH, Lai YC, Wu MS, Dong XF, Chen YZ, Li WF, Yang FQ, Yang YY, Zhong TM, Wang GD, Pang QQ, Chen K, Peng N, Nong JL, Su Z, Yu YQ, Ye L, Zeng FJ, Liu SP, Wang XY, Yao HB, Qin C, Zhang YY, Liu J, Li MJ, Liang YR, Wu PS, Li FX, Mao XS, Chen SC, Ou JJ, Luo M, Lu SC, Li ZC, Huang S, Su JY, Chen H, Zhang YG, Liang XM, Ma YL, Ma L, Zhong JH; GUIDANCE investigators. Prognostic value of radiological and pathological complete response following immune-based conversion therapy in patients with unresectable hepatocellular carcinoma (GUIDANCE004). JHEP Rep. 2025 Sep 8;7(11):101587. doi: 10.1016/j.jhepr.2025.101587. eCollection 2025 Nov. PubMed 41143241 ↗
  • Yang DL, Peng N, Nong JL, Chen K, Su Z, Yu YQ, Ye L, Zeng FJ, Liu SP, Yan YH, Wang XY, Yao HB, Yang FQ, Li WF, Qin C, Wu MS, Yang YY, Dong XF, Li MJ, Liu J, Liang YR, Wu PS, Zhong TM, Lai YC, Chen YZ, Pang QQ, Wang GD, Li FX, Mao XS, Chen SC, Ou JJ, Huo RR, Liang XM, Xiang BD, Ma L, Zhong JH; GUIDANCE Investigators. Survival Benefit of Hepatectomy after Complete or Partial Response to Conversion Therapy in Unresectable Hepatocellular Carcinoma (GUIDANCE003): A Multicenter Study. Liver Cancer. 2025 Apr 23;14(6):687-703. doi: 10.1159/000546052. eCollection 2025 Dec. PubMed 40496213 ↗
  • Yang DL, Ye L, Zeng FJ, Liu J, Yao HB, Nong JL, Liu SP, Peng N, Li WF, Wu PS, Qin C, Su Z, Ou JJ, Dong XF, Yan YH, Zhong TM, Mao XS, Wu MS, Chen YZ, Wang GD, Li MJ, Wang XY, Yang FQ, Liang YR, Chen SC, Yang YY, Chen K, Li FX, Lai YC, Pang QQ, Liang XM, You XM, Xiang BD, Yu YQ, Ma L, Zhong JH; GUIDANCE investigators. Multicenter, retrospective GUIDANCE001 study comparing transarterial chemoembolization with or without tyrosine kinase and immune checkpoint inhibitors as conversion therapy to treat unresectable hepatocellular carcinoma: Survival benefit in intermediate or advanced, but not early, stages. Hepatology. 2025 Aug 1;82(2):357-369. doi: 10.1097/HEP.0000000000001229. Epub 2025 Jan 15. PubMed 39908184 ↗

Individual participant data

Plan to share: Yes — The data that support the findings of this study are available on request from the corresponding author, Jian-Hong Zhong, upon reasonable request.

Supporting information: Study protocol, Csr

08

Registry details

Key details

Study ID
NCT06405321
Lead sponsor
Guangxi Medical University
Responsible party
Jian-Hong Zhong (Principal Investigator, Guangxi Medical University) — Principal investigator
First posted
May 8, 2024
Start date
Jan 1, 2019
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 14, 2026

Study contacts

Jian-Hong Zhong, Ph.D
Contact
zhongjianhong66@163.com
+86 771 5301253 ext. +86
Liang Ma, MD
Contact
malianggxyd@163.com
+86 771 5301253 ext. +86
Jian-Hong Zhong, Ph.D
principal investigator · Guangxi Medical University Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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