Hepato Cellular Carcinoma (HCC)NCT07142213
Effect and Mechanism of ALPPS Operation on Liver Regeneration
An observational study of Hepato Cellular Carcinoma (HCC) and Hepatobiliary Cancers, run by Haitao Zhao, MD at 1 site in China.
Trial summary
Hepatobiliary malignancies-principally hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA)-are highly aggressive and often diagnosed at advanced stages. Curative-intent liver resection remains the standard for resectable disease; however, postoperative outcomes depend on an adequate functional future liver… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepato Cellular Carcinoma (HCC), Hepatobiliary Cancers, Liver Cancer
- What is being tested?
- ALPPS
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2028
- How long will I take part?
- 1 Year
- 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 radiologically or pathologically confirmed hepatobiliary malignancies
Who may be able to join
- Age: Patients aged 18 to 75 years
- Diagnosis established: A diagnosis of hepatobiliary malignancy (including hepatocellular carcinoma and cholangiocarcinoma) was confirmed and evaluated as suitable for ALPPS surgery
- Liver function status: preoperative Child-Pugh score A or B, MELD score ≤15, with sufficient liver function reserve for operation
- Tumor characteristics: bilobal or complex tumors of the liver with large tumor areas requiring ALPPS to ensure adequate residual liver volume (FLR/TLV<30% or FLR/BW<0.5)
- Preoperative assessment: Imaging showed that future liver residual (FLR) was insufficient to support standard hepatectomy, and liver volume must be increased by ALPPS
- FLR enlargement: Postoperative assessment of FLR enlargement as expected (at least 30% enlargement or FLR/BW above 0.5) for a second procedure
- No distant metastases: No unresectable extrahepatic metastases, except for resectable lung metastases
Who cannot join
- Preoperative FLR insufficiency: Residual liver volume (FLR) did not increase sufficiently after the first step (<30% increase or FLR/BW <0.5) to be suitable for the second step
- Extrahepatic metastasis: unresectable distant metastasis, such as extensive metastasis of bone, lung, etc
- Severe liver disease: very poor liver function before surgery, Child-Pugh grade C or severe liver sclerosis during surgery (e.g. Metavir≥F3 or 30% or more hepatic steatosis)
- Major comorbidities: Major illnesses such as severe cardiovascular disease, kidney failure, or respiratory failure that do not tolerate major surgery
- Postoperative complications: Serious postoperative complications (such as liver failure, infection, etc.) after the first step are not suitable for the second step
- Evaluation of adverse surgery: After the first procedure, FLR blood supply or function is abnormal, affecting liver regeneration
- Pregnancy and lactation: pregnant or lactating women
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Haitao Zhao, 86-010-69156042, zhaoht@pumch.cn
About this study
Official title: Effect and Mechanism of Combined Hepatectomy and Portal Vein Ligation Staged Hepatectomy (ALPPS) on Liver Regeneration in Patients With Hepatobiliary Malignancy
Hepatobiliary malignancies-principally hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA)-are highly aggressive and often diagnosed at advanced stages. Curative-intent liver resection remains the standard for resectable disease; however, postoperative outcomes depend on an adequate functional future liver remnant (FLR). Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) induces rapid FLR hypertrophy and has expanded resection eligibility compared with conventional two-stage hepatectomy by shortening the interval to definitive resection.
Key uncertainties persist regarding the quality of ALPPS-induced regeneration and its relationship to long-term oncologic outcomes, including recurrence and metastasis. This observational study enrolls patients deemed suitable for ALPPS at Peking Union Medical College Hospital. Perioperative care follows institutional standards; no therapeutic procedures are altered for research purposes. The investigators will collect clinically available liver tissue and relevant medical data obtained during standard surgical care to characterize cellular and molecular programs of regeneration across the ALPPS stages.
High-throughput profiling-including single-cell and spatial transcriptomics-will be used to define cell-type composition, transcriptional states, and signaling pathways associated with regeneration. The primary objective is to describe cellular and gene-expression changes in regenerating liver induced by ALPPS. Secondary objectives include exploring associations between regenerative quality and short- and long-term clinical outcomes. Findings are expected to inform potential therapeutic targets and strategies to enhance safe regeneration and improve postoperative prognosis.
- Being tested
- ALPPS
- Keywords
- liver regeneration, ALPPS, hepatectomy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPPSProcedure or surgery
In recent years, Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) provides new hope for the solution of large/unresectable hepatobiliary malignancies. This technique promotes the rapid proliferation and regeneration of the remaining liver by separating the liver and ligation of the portal vein, so that the patients whose original liver function is not enough to tolerate large-scale liver resection can complete liver regeneration in a short time, so as to perform secondary resection. Compared with traditional two-stage hepatectomy, ALPPS significantly speeds up the rate of liver regeneration, shortens the waiting time for a second surgery, and provides a safer radical treatment for tumors in high-risk patients.
| Study group | Role | What they receive |
|---|---|---|
| ALPPS group | Patietns who undergoing associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) Receives: Procedure: ALPPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual liver volume
Residual liver volume of the future liver remnant (FLR) immediately before Stage-2 resection, quantified by contrast-enhanced CT-based 3D volumetry; reported in milliliters (mL) and as percent of standard liver volume (%SLV).
Measured: Time Frame: Day 7 (±2 days) and Day 14 (±2 days) after Stage-1 ALPPS; primary analysis uses the last assessment obtained prior to Stage-2 (up to Day 28).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Jan 2020
- Primary completion31 Dec 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepato Cellular Carcinoma (HCC)Studies 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
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Haitao Zhao, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haitao Zhao, MD, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142213
- Sponsor's protocol ID
- K7100
- Status last verified
- Dec 2024
- First submitted
- 13 Jan 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please contact the research contact person and submit a reasonable research proposal at the time of application
Publications
Wen Z, Jin Z, Xu B, Zhu H, Wang J, Chen W, Zhang J, Huang K, Lan Z, Meng B, Mao W, Zhu H, Zhang L, Lu T, Zeng J, Bao L, Lau WY, Guo Y. Hepatic artery restriction operation combined with ALPPS (HARO-ALPPS), a novel ALPPS procedure for the treatment of hepatocellular carcinoma with severe fibrosis: retrospective clinical cohort study. Int J Surg. 2024 Sep 1;110(9):5662-5671. doi: 10.1097/JS9.0000000000001679.
PubMed 38768472
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Mechanism of Combined Hepatectomy and Portal Vein Ligation Staged Hepatectomy (ALPPS) on Liver Regeneration in Patients With Hepatobiliary Malignancy
- ClinicalTrials.gov ID
- NCT07142213
- Acronym / sponsor ID
- K7100
- Keywords
- liver regeneration, ALPPS, hepatectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Haitao Zhao, MDUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Aug 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.
Hepatobiliary malignancies-principally hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA)-are highly aggressive and often diagnosed at advanced stages. Curative-intent liver resection remains the standard for resectable disease; however, postoperative outcomes depend on an adequate functional future liver remnant (FLR). Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) induces rapid FLR hypertrophy and has expanded resection eligibility compared with conventional two-stage hepatectomy by shortening the interval to definitive resection.
Key uncertainties persist regarding the quality of ALPPS-induced regeneration and its relationship to long-term oncologic outcomes, including recurrence and metastasis. This observational study enrolls patients deemed suitable for ALPPS at Peking Union Medical College Hospital. Perioperative care follows institutional standards; no therapeutic procedures are altered for research purposes. The investigators will collect clinically available liver tissue and relevant medical data obtained during standard surgical care to characterize cellular and molecular programs of regeneration across the ALPPS stages.
High-throughput profiling-including single-cell and spatial transcriptomics-will be used to define cell-type composition, transcriptional states, and signaling pathways associated with regeneration. The primary objective is to describe cellular and gene-expression changes in regenerating liver induced by ALPPS. Secondary objectives include exploring associations between regenerative quality and short- and long-term clinical outcomes. Findings are expected to inform potential therapeutic targets and strategies to enhance safe regeneration and improve postoperative prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALPPS group | – | Procedure: ALPPSPatietns who undergoing associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with radiologically or pathologically confirmed hepatobiliary malignancies
Key inclusion criteria (7 listed)
- Age: Patients aged 18 to 75 years
- Diagnosis established: A diagnosis of hepatobiliary malignancy (including hepatocellular carcinoma and cholangiocarcinoma) was confirmed and evaluated as suitable for ALPPS surgery
- Liver function status: preoperative Child-Pugh score A or B, MELD score ≤15, with sufficient liver function reserve for operation
- Tumor characteristics: bilobal or complex tumors of the liver with large tumor areas requiring ALPPS to ensure adequate residual liver volume (FLR/TLV<30% or FLR/BW<0.5)
- Preoperative assessment: Imaging showed that future liver residual (FLR) was insufficient to support standard hepatectomy, and liver volume must be increased by ALPPS
Key exclusion criteria (7 listed)
- Preoperative FLR insufficiency: Residual liver volume (FLR) did not increase sufficiently after the first step (<30% increase or FLR/BW <0.5) to be suitable for the second step
- Extrahepatic metastasis: unresectable distant metastasis, such as extensive metastasis of bone, lung, etc
- Severe liver disease: very poor liver function before surgery, Child-Pugh grade C or severe liver sclerosis during surgery (e.g. Metavir≥F3 or 30% or more hepatic steatosis)
- Major comorbidities: Major illnesses such as severe cardiovascular disease, kidney failure, or respiratory failure that do not tolerate major surgery
- Postoperative complications: Serious postoperative complications (such as liver failure, infection, etc.) after the first step are not suitable for the second step
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 |
|---|---|---|
| ALPPSIn recent years, Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) provides new hope for the solution of large/unresectable hepatobiliary malignancies. This technique promotes the rapid proliferation and regeneration of the remaining liver by separating the liver and ligation of the portal vein, so that the patients whose original liver function is not enough to tolerate large-scale liver resection can complete liver regeneration in a short time, so as to perform secondary resection. Compared with traditional two-stage hepatectomy, ALPPS significantly speeds up the rate of liver regeneration, shortens the waiting time for a second surgery, and provides a safer radical treatment for tumors in high-risk patients. | Procedure or surgery | ALPPS group |
Primary outcome
Residual liver volume
Time frame: Time Frame: Day 7 (±2 days) and Day 14 (±2 days) after Stage-1 ALPPS; primary analysis uses the last assessment obtained prior to Stage-2 (up to Day 28).
Residual liver volume of the future liver remnant (FLR) immediately before Stage-2 resection, quantified by contrast-enhanced CT-based 3D volumetry; reported in milliliters (mL) and as percent of standard liver volume (%SLV).
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 26 Aug 2025.
- Results publication: PubMed 38768472Wen Z, Jin Z, Xu B, Zhu H, Wang J, Chen W, Zhang J, Huang K, Lan Z, Meng B, Mao W, Zhu H, Zhang L, Lu T, Zeng J, Bao L, Lau WY, Guo Y. Hepatic artery restriction operation combined with ALPPS (HARO-ALPPS), a novel ALPPS procedure for the treatment of hepatocellular carcinoma with severe fibrosis: retrospective clinical cohort study. Int J Surg. 2024 Sep 1;110(9):5662-5671. doi: 10.1097/JS9.0000000000001679.
- Individual participant dataSharing planned: Yes. Please contact the research contact person and submit a reasonable research proposal at the time of application
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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.
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 Hepato Cellular Carcinoma (HCC) and Hepatobiliary Cancers, run by Haitao Zhao, MD 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 7 inclusion and 7 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 26 Aug 2025. 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 Haitao Zhao (86-010-69156042, zhaoht@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual liver volume (time frame: Time Frame: Day 7 (±2 days) and Day 14 (±2 days) after Stage-1 ALPPS; primary analysis uses the last assessment obtained prior to Stage-2 (up to Day 28).). 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 NCT07142213, which also lists 1 linked publication.
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 26 Aug 2025.