NCT06405321

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jan 2019Dec 2026

Study Start

First participant enrolled

January 1, 2019

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

8 years

First QC Date

May 4, 2024

Last Update Submit

January 13, 2026

Conditions

Keywords

conversion therapyneoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    1 year overall survival

    1 year

Secondary Outcomes (1)

  • progression-free survival

    1 year

Study Arms (1)

Conversion or Neoadjuvant Therapy

Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy.

Drug: Conversion or neoadjuvant therapy.

Interventions

Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy.

Conversion or Neoadjuvant Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jian-Hong Zhong

Nanning, China, 530021, China

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Jian-Hong Zhong, Ph.D

    Guangxi Medical University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2024

First Posted

May 8, 2024

Study Start

January 1, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
After papers were published.

Locations