ClinicalTrials.gg
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

From the registry’s dates

  • Started Jan 2019; still recruiting 7 years 10 months later.

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 34 studies in Carcinoma, Hepatocellular by Guangxi Medical University — 6 open to participants now, 7 under way, 4 of them phase 3. Carcinoma, Hepatocellular · Guangxi Medical University.

Started
2019
with 7 others
Observational
5 of 34
2 open now
Registered
31st of 34
by date

Among the 34 studies in Carcinoma, Hepatocellular by Guangxi Medical University, this one is one of 8 that started in 2019, is one of 5 observational ones, and was the 31st registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

6 of the 34 studies in Carcinoma, Hepatocellular by Guangxi Medical University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 34 studies in Carcinoma, Hepatocellular by Guangxi Medical University, or all of them as a file.
02

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.

03

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • conversion therapy
  • neoadjuvant therapy
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Concurrent with other within 5 years.
  • Incomplete medical data.
  • Follow-up time less than 3 months.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
08

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, Clinical study report

Time frame: After papers were published.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2019 (actual). Primary completion is estimated for Dec 2026, 95 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2024
First posted
May 8, 2024
StartActual
Jan 1, 2019
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jan 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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