Unresectable Hepatocellular CarcinomTHAI-CONVERTNCT07206511
Conversion Therapy Using TACE/HAIC With Anti-Angiogenic and Immunotherapy for Initially Unresectable Hepatocellular Carcinoma Achieving Complete Response or Resectability, Followed by Surgery or Continued Systemic Treatment: A Prospective Cohort Study
An observational study of Unresectable Hepatocellular Carcinom, run by Shanghai Zhongshan Hospital.
Trial summary
This is a prospective cohort study designed to evaluate the effectiveness and safety of two post-conversion treatment strategies for patients with initially unresectable hepatocellular carcinoma (uHCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Hepatocellular Carcinom
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2025to 31 Dec 2028
- How long will I take part?
- 36 Months
- 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: Participants are adults (18-75 years) with initially unresectable hepatocellular carcinoma (uHCC) diagnosed by histology/cytology or according to AASLD criteria and Chinese national guidelines. These patients have received conversion therapy consisting of transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After conversion therapy, participants have achieved radiological complete response (rCR) or reached resectability criteria and then either undergo curative liver resection or continue systemic therapy. Eligible patients must have Child-Pugh class A or B liver function and ECOG performance status 0-1.
Who may be able to join
- Signed written informed consent.
- Age 18-75 years.
- Hepatocellular carcinoma (HCC) confirmed by histology/cytology or diagnosed according to the AASLD criteria.
- Initially unresectable HCC (uHCC), defined according to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition) and the Chinese Expert Consensus on Conversion and Perioperative Therapy for Primary Liver Cancer (2024 edition): HCC considered unsafe for curative resection due to inability to ensure both oncological completeness (R0 resection) and functional hepatic reserve (adequate future liver remnant with good vascular supply and biliary drainage to maintain postoperative liver function and minimize morbidity and mortality). Mainly includes CNLC stage Ib-IIIa or potentially resectable cases. Some stage Ia patients may also be considered uHCC if the tumor is adjacent to major intrahepatic vessels or involves the first/second hepatic hilum making R0 resection infeasible, or if severe cirrhosis increases risk of postoperative liver failure and complications; these can be considered after successful conversion and supportive treatment.
- No prior systemic therapy before conversion treatment.
- Conversion therapy regimen must include TACE or HAIC plus anti-angiogenic agents and immune checkpoint inhibitors (ICIs).
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- Anti-angiogenic agents may include lenvatinib, sorafenib, apatinib, donafenib, anlotinib, bevacizumab.
- ICIs may include pembrolizumab, atezolizumab, nivolumab, sintilimab, tislelizumab, toripalimab, penpulimab, cadonilimab, KN-046.
- After conversion therapy, hepatic lesions achieve radiological complete response (rCR) by mRECIST criteria on contrast-enhanced CT or MRI, or are assessed to have reached resectability criteria (eligible for curative hepatectomy or downstaging enabling safe surgery).
- After achieving rCR or resectability, patients must have received either liver resection or continued systemic therapy with scheduled follow-up.
- Child-Pugh class A or B liver function.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
Who cannot join
- Presence of another primary malignancy in other organs.
- History of other malignancies.
- Recurrent HCC occurring <2 years after previous curative surgery or adjuvant therapy.
- Received treatments other than TACE or HAIC plus anti-angiogenic agents and ICIs during the conversion phase.
- Received treatments during postoperative or maintenance systemic therapy that differ from the initial conversion regimen.
- Severe organ dysfunction.
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- Incomplete radiological assessment data after treatment.
- Child-Pugh class C liver function.
- Pregnant or breastfeeding women.
- Patients undergoing only functional future liver remnant (FLR) hypertrophy procedures (e.g., ALPPS or PVE) for insufficient FLR without other criteria for uHCC conversion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Outcomes of Initially Unresectable Hepatocellular Carcinoma Patients Receiving TACE/HAIC Plus Anti-Angiogenic Agents and Immune Checkpoint Inhibitors as Conversion Therapy, Achieving Complete Radiological Response or Resectability, Followed by Systemic Treatment or Surgical Resection: A Prospective Cohort Study
This is a prospective cohort study designed to evaluate the effectiveness and safety of two post-conversion treatment strategies for patients with initially unresectable hepatocellular carcinoma (uHCC). Participants first receive conversion therapy with transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After this therapy, patients who achieve complete radiological response (rCR) or meet resectability criteria will either undergo surgical resection or continue systemic therapy. The study aims to compare outcomes between these two strategies to help guide treatment decisions for advanced liver cancer.
- Conditions
- Unresectable Hepatocellular Carcinom
- Keywords
- Hepatocellular Carcinoma, Conversion Therapy, Radiological Complete Response, Systemic Therapy, Surgical Resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic Therapy Group | Patients with initially unresectable hepatocellular carcinoma who achieved complete radiological response or resectability after TACE/HAIC + anti-angiogenic agents + immune checkpoint inhibitors and then continued systemic therapy. | |
| Surgical Resection Group | Patients with initially unresectable hepatocellular carcinoma who achieved complete radiological response or resectability after TACE/HAIC + anti-angiogenic agents + immune checkpoint inhibitors and then underwent surgical resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
Defined as the time from the date of achieving rCR or resectability criteria to the time of becoming inoperable, recurrence, progression, or death from any cause for uHCC patients.
Measured: From initiation of post-conversion therapy to the first documented event (recurrence, progression, or death), up to 36 months
Secondary outcomes (4)
2-Year Event-Free Survival (EFS) Rate
Defined as the rate of no events (recurrence, progression, or death from any cause) occurring in rCR patients over 2 years.
Measured: 2 years after initiation of post-conversion therapy
Overall Survival (OS)
Defined as the survival time from the day of achieving rCR to death from any cause。
Measured: Up to 36 months after initiation of post-conversion therapy
Treatment Safety
: The incidence of adverse events in the surgery group and the systemic therapy group. Adverse events recorded on the CRF will be mapped to preferred terms using the Medical Dictionary for Regulatory Activities (MedDRA). Severity, seriousness/grade, and the relationship with the study treatment will be assessed by the investigators. The seriousness/grade will be defined according to the National Cancer Institute (NCI) CTCAE v5.0.
Measured: From initiation of post-conversion therapy through 30 days after last treatment or surgery, up to 36 months follow-up
Cost-Effectiveness of Post-Conversion Treatment Strategies
The cost-effectiveness ratio (C/E) is defined as the ratio of time to an event (EFS) or overall survival (death) from rCR to all direct costs (medical expenses, including outpatient and inpatient), and will be compared between the two groups.
Measured: Up to 36 months after initiation of post-conversion therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start9 Oct 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomStudies 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
- Prospective
- Enrolment
- 278 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206511
- Sponsor's protocol ID
- B2025-437R
- Acronym
- THAI-CONVERT
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Initially Unresectable Hepatocellular Carcinoma Patients Receiving TACE/HAIC Plus Anti-Angiogenic Agents and Immune Checkpoint Inhibitors as Conversion Therapy, Achieving Complete Radiological Response or Resectability, Followed by Systemic Treatment or Surgical Resection: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07206511
- Acronym / sponsor ID
- THAI-CONVERT / B2025-437R
- Conditions
- Unresectable Hepatocellular Carcinom
- Keywords
- Hepatocellular Carcinoma, Conversion Therapy, Radiological Complete Response, Systemic Therapy, Surgical Resection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 9 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Oct 2025 (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 is a prospective cohort study designed to evaluate the effectiveness and safety of two post-conversion treatment strategies for patients with initially unresectable hepatocellular carcinoma (uHCC). Participants first receive conversion therapy with transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After this therapy, patients who achieve complete radiological response (rCR) or meet resectability criteria will either undergo surgical resection or continue systemic therapy. The study aims to compare outcomes between these two strategies to help guide treatment decisions for advanced liver cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Therapy Group | – | –Patients with initially unresectable hepatocellular carcinoma who achieved complete radiological response or resectability after TACE/HAIC + anti-angiogenic agents + immune checkpoint inhibitors and then continued systemic therapy. |
| Surgical Resection Group | – | –Patients with initially unresectable hepatocellular carcinoma who achieved complete radiological response or resectability after TACE/HAIC + anti-angiogenic agents + immune checkpoint inhibitors and then underwent surgical resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are adults (18-75 years) with initially unresectable hepatocellular carcinoma (uHCC) diagnosed by histology/cytology or according to AASLD criteria and Chinese national guidelines. These patients have received conversion therapy consisting of transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After conversion therapy, participants have achieved radiological complete response (rCR) or reached resectability criteria and then either undergo curative liver resection or continue systemic therapy. Eligible patients must have Child-Pugh class A or B liver function and ECOG performance status 0-1.
Key inclusion criteria (12 listed)
- Signed written informed consent.
- Age 18-75 years.
- Hepatocellular carcinoma (HCC) confirmed by histology/cytology or diagnosed according to the AASLD criteria.
- Initially unresectable HCC (uHCC), defined according to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition) and the Chinese Expert Consensus on Conversion and Perioperative Therapy for Primary Liver Cancer (2024 edition): HCC considered unsafe for curative resection due to inability to ensure both oncological completeness (R0 resection) and functional hepatic reserve (adequate future liver remnant with good vascular supply and biliary drainage to maintain postoperative liver function and minimize morbidity and mortality). Mainly includes CNLC stage Ib-IIIa or potentially resectable cases. Some stage Ia patients may also be considered uHCC if the tumor is adjacent to major intrahepatic vessels or involves the first/second hepatic hilum making R0 resection infeasible, or if severe cirrhosis increases risk of postoperative liver failure and complications; these can be considered after successful conversion and supportive treatment.
- No prior systemic therapy before conversion treatment.
Key exclusion criteria (10 listed)
- Presence of another primary malignancy in other organs.
- History of other malignancies.
- Recurrent HCC occurring <2 years after previous curative surgery or adjuvant therapy.
- Received treatments other than TACE or HAIC plus anti-angiogenic agents and ICIs during the conversion phase.
- Received treatments during postoperative or maintenance systemic therapy that differ from the initial conversion regimen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Event-Free Survival (EFS)
Time frame: From initiation of post-conversion therapy to the first documented event (recurrence, progression, or death), up to 36 months
Defined as the time from the date of achieving rCR or resectability criteria to the time of becoming inoperable, recurrence, progression, or death from any cause for uHCC patients.
4 secondary outcomes
2-Year Event-Free Survival (EFS) Rate
Time frame: 2 years after initiation of post-conversion therapy
Overall Survival (OS)
Time frame: Up to 36 months after initiation of post-conversion therapy
Treatment Safety
Time frame: From initiation of post-conversion therapy through 30 days after last treatment or surgery, up to 36 months follow-up
Cost-Effectiveness of Post-Conversion Treatment Strategies
Time frame: Up to 36 months after initiation of post-conversion therapy
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 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Hepatocellular Carcinom, run by Shanghai Zhongshan Hospital.
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 12 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ao Huang, PhD (+86-21-64041990, huang.ao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: From initiation of post-conversion therapy to the first documented event (recurrence, progression, or death), up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2025.