Hepatocellular CarcinomaNCT06405321
Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Conversion or neoadjuvant therapy.
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatocellular carcinoma who received conversion or neoadjuvant therapy as initial treatment would be included.
Who may be able to join
- 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.
Who cannot join
- Concurrent with other malignancies within 5 years.
- Incomplete medical data.
- Follow-up time less than 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jian-Hong Zhong
Nanning, China, 530021
Jian-Hong Zhong, PhD, 0771 5301253 ext. +86, zhongjianhong66@163.com
Liang Ma, MD, 0771 5301253 ext. +86, malianggxyd@163.com
About this study
Official title: Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma: A Multicenter Retrospective Study in Guangxi, China (GUIDANCE)
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Conversion or neoadjuvant therapy.
- Keywords
- conversion therapy, neoadjuvant therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion or neoadjuvant therapy.Drug
Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Conversion or Neoadjuvant Therapy | Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy. Receives: Drug: Conversion or neoadjuvant therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
1 year overall survival
Measured: 1 year
Secondary outcomes (1)
progression-free survival
1 year progression-free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
- Investigators
- Jian-Hong Zhong, Ph.D, Principal investigator, Guangxi Medical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405321
- Sponsor's protocol ID
- GUIDANCE
- Status last verified
- Jan 2026
- First submitted
- 4 May 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available on request from the corresponding author, Jian-Hong Zhong, upon reasonable request.
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 41143241Yang 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 40496213Yang 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma: A Multicenter Retrospective Study in Guangxi, China (GUIDANCE)
- ClinicalTrials.gov ID
- NCT06405321
- Acronym / sponsor ID
- GUIDANCE
- Conditions
- Hepatocellular Carcinoma
- Keywords
- conversion therapy, neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conversion or Neoadjuvant Therapy | – | Drug: Conversion or neoadjuvant therapy.Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma who received conversion or neoadjuvant therapy as initial treatment would be included.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Concurrent with other malignancies within 5 years.
- Incomplete medical data.
- Follow-up time less than 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conversion or neoadjuvant therapy.Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy. | Drug | Conversion or Neoadjuvant Therapy |
Primary outcome
Overall survival
Time frame: 1 year
1 year overall survival
1 secondary outcome
progression-free survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Results publication: PubMed 41143241Yang 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.
- Results publication: PubMed 40496213Yang 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.
- Results publication: PubMed 39908184Yang 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.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available on request from the corresponding author, Jian-Hong Zhong, upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian-Hong Zhong, Ph.D principal investigator
Guangxi Medical University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian-Hong Zhong, Ph.D (+86 771 5301253 ext. +86, zhongjianhong66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06405321, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.