Huge Hepatocellular Carcinoma (HCC) (>10cm)NCT07639294
The Application of Locoregional Therapy Combined With Systemic Therapy in the Perioperative Period of Huge Hepatocellular Carcinoma: A Retrospective Cohort Study
An observational study of Huge Hepatocellular Carcinoma (HCC) (>10cm), run by Tongji Hospital at 1 site in China.
Trial summary
This retrospective cohort study collected data of patients with huge hepatocellular carcinoma (HCC) treated between June 1, 2018, and December 31, 2023, through the hospital information system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Huge Hepatocellular Carcinoma (HCC) (>10cm)
- What is being tested?
- hepatectomy without immune checkpoint inhibitors-based adjuvant therapy, hepatectomy with immune checkpoint inhibitors-based adjuvant therapy and neoadjuvant conversion therapy followed by surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 715 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were identified as potentially convertible huge HCC and underwent treatment between June 2018 and December 2023
Who may be able to join
- pathologically or clinically diagnosed HCC with a tumor diameter exceeding 10 cm on initial computed tomography (CT) or magnetic resonance imaging (MRI);
- ≤ 3 tumor nodules;
- portal vein tumor thrombus (PVTT) that had not invaded the main portal vein or the contralateral branch of portal vein (Vp0-3 PVTT);
- absence of extrahepatic metastasis; (5) Child-Pugh score of 5-7 and Eastern Cooperative Oncology Group performance status of 0-1.
Who cannot join
- mixed tumors with HCC and cholangiocarcinoma;
- recurrent HCC;
- tumor thrombus invading the inferior vena cava;
- combined with any malignancy other than HCC;
- incomplete clinical or follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
This retrospective cohort study collected data of patients with huge hepatocellular carcinoma (HCC) treated between June 1, 2018, and December 31, 2023, through the hospital information system. Patients were divided into a neoadjuvant conversion-first cohort and an upfront surgery cohort based on whether they received preoperative locoregional therapy combined with targeted and immunotherapy. The conversion-first cohort was further stratified into a conversion surgery group and a non-surgery group according to whether curative-intent hepatectomy was ultimately achieved. The upfront surgery cohort was divided into a postoperative adjuvant therapy group and a postoperative surveillance group based on whether adjuvant immunotherapy was administered after surgery. The primary objective was to analyze differences in overall survival (OS) and progression-free survival (PFS) among the four groups and to evaluate the impact of neoadjuvant conversion therapy on the safety of hepatectomy.
- Being tested
- hepatectomy without immune checkpoint inhibitors-based adjuvant therapy, hepatectomy with immune checkpoint inhibitors-based adjuvant therapy, neoadjuvant conversion therapy followed by surgery, Non-surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatectomy without immune checkpoint inhibitors-based adjuvant therapyProcedure or surgery
All procedures were performed by senior hepato-pancreato-biliary surgeons who completed over 100 hepatectomy procedures annually. Intraoperative ultrasound was routinely performed to identify any potential tumor nodules that were not detected before surgery and to help rule out parenchymal transection plane. The resection margin should extend 1 cm beyond the tumor edge whenever possible. Pringle's maneuver and the low central venous pressure technique were performed routinely.For difficult hepatectomy, the anterior approach (parenchymal transection without prior mobilization of the liver) was applied and the hepatic pedicle and the inferior vena cava below the liver were clamped simultaneously for better hepatic vascular inflow and outflow control. Liver parenchymal transection was performed by an ultrasonic scalpel. After surgery, all patients were followed up according to the visit schedules and contents recommended by the Chinese guidelines for HCC.
hepatectomy with immune checkpoint inhibitors-based adjuvant therapyProcedure or surgery
After surgery, patients who agreed to receive postoperative adjuvant therapy began to undergo immunotherapy when recovered well from the surgery and alanine aminotransferase and aspartate aminotransferase were both less than 80 U/L and total bilirubin was less than 2 mg/dL. Immune checkpoint inhibitors (ICIs) included pembrolizumab, atezolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab. The specific agents of ICIs were determined by the patients' wishes and consultation with their attending physicians. ICIs were injection once every 3 weeks for 12 months and would be terminated when disease progressed or intolerable toxicity occurred. Meanwhile, some patients underwent adjuvant transarterial chemoembolization (TACE) and/or target therapy.
neoadjuvant conversion therapy followed by surgeryProcedure or surgery
Patients were treated preoperatively with a combination of immune checkpoint inhibitors (ICIs), targeted drugs, and locoregional interventions, such as transarterial chemoembolization (TACE) and/or and/or hepatic artery infusion chemotherapy (HAIC).ICIs included pembrolizumab, atezolizumab, tislelizumab, sintilimab, camrelizumab, toripalimab, and durvalumab. Targeted drugs included lenvatinib, bevacizumab, donafenib, sorafenib, regorafenib, and apatinib. The choice of different locoregional therapies and systemic therapy agents for HCC was made by weighing the patient's wishes, cost considerations, and multidisciplinary team (MDT) discussions. ICIs and targeted drugs were used until the disease progressed or an intolerable adverse event occurred.
Non-surgeryDrug
Patients who received the neoadjuvant conversion therapy but eventually not underwent surgery
| Study group | Role | What they receive |
|---|---|---|
| upfront surgery with active surveillance | Not described Receives: Procedure: hepatectomy without immune checkpoint inhibitors-based adjuvant therapy | |
| surgery with adjuvant treatment | Not described Receives: Procedure: hepatectomy with immune checkpoint inhibitors-based adjuvant therapy | |
| neoadjuvant conversion surgery group | Not described Receives: Procedure: neoadjuvant conversion therapy followed by surgery | |
| non-surgery | Not described Receives: Drug: Non-surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: From date of treatment until the date of death from any cause, assessed up to 66 months
Secondary outcomes (2)
Progression-free survival
Measured: from the date of the first treatment to the date of tumor progression, assessed up to 66 months
Textbook Outcome in Liver Surgery
A comprehensive indicator takes into account intraoperative incidents, postoperative bile leakage, postoperative liver failure, postoperative complications, R0 resection, readmission, and mortality
Measured: Within 90 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jun 2018
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huge Hepatocellular Carcinoma (HCC) (>10cm)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Qi, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639294
- Sponsor's protocol ID
- Huge-HCC-retro001
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Locoregional Therapy Combined With Systemic Therapy in the Perioperative Period of Huge Hepatocellular Carcinoma: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07639294
- Acronym / sponsor ID
- Huge-HCC-retro001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Jun 2026 (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 retrospective cohort study collected data of patients with huge hepatocellular carcinoma (HCC) treated between June 1, 2018, and December 31, 2023, through the hospital information system. Patients were divided into a neoadjuvant conversion-first cohort and an upfront surgery cohort based on whether they received preoperative locoregional therapy combined with targeted and immunotherapy. The conversion-first cohort was further stratified into a conversion surgery group and a non-surgery group according to whether curative-intent hepatectomy was ultimately achieved. The upfront surgery cohort was divided into a postoperative adjuvant therapy group and a postoperative surveillance group based on whether adjuvant immunotherapy was administered after surgery. The primary objective was to analyze differences in overall survival (OS) and progression-free survival (PFS) among the four groups and to evaluate the impact of neoadjuvant conversion therapy on the safety of hepatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| upfront surgery with active surveillance | – | Procedure: hepatectomy without immune checkpoint inhibitors-based adjuvant therapy |
| surgery with adjuvant treatment | – | Procedure: hepatectomy with immune checkpoint inhibitors-based adjuvant therapy |
| neoadjuvant conversion surgery group | – | Procedure: neoadjuvant conversion therapy followed by surgery |
| non-surgery | – | Drug: Non-surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were identified as potentially convertible huge HCC and underwent treatment between June 2018 and December 2023
Key inclusion criteria (4 listed)
- pathologically or clinically diagnosed HCC with a tumor diameter exceeding 10 cm on initial computed tomography (CT) or magnetic resonance imaging (MRI);
- ≤ 3 tumor nodules;
- portal vein tumor thrombus (PVTT) that had not invaded the main portal vein or the contralateral branch of portal vein (Vp0-3 PVTT);
- absence of extrahepatic metastasis; (5) Child-Pugh score of 5-7 and Eastern Cooperative Oncology Group performance status of 0-1.
Key exclusion criteria (5 listed)
- mixed tumors with HCC and cholangiocarcinoma;
- recurrent HCC;
- tumor thrombus invading the inferior vena cava;
- combined with any malignancy other than HCC;
- incomplete clinical or follow-up data.
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 |
|---|---|---|
| hepatectomy without immune checkpoint inhibitors-based adjuvant therapyAll procedures were performed by senior hepato-pancreato-biliary surgeons who completed over 100 hepatectomy procedures annually. Intraoperative ultrasound was routinely performed to identify any potential tumor nodules that were not detected before surgery and to help rule out parenchymal transection plane. The resection margin should extend 1 cm beyond the tumor edge whenever possible. Pringle's maneuver and the low central venous pressure technique were performed routinely.For difficult hepatectomy, the anterior approach (parenchymal transection without prior mobilization of the liver) was applied and the hepatic pedicle and the inferior vena cava below the liver were clamped simultaneously for better hepatic vascular inflow and outflow control. Liver parenchymal transection was performed by an ultrasonic scalpel. After surgery, all patients were followed up according to the visit schedules and contents recommended by the Chinese guidelines for HCC. | Procedure or surgery | upfront surgery with active surveillance |
| hepatectomy with immune checkpoint inhibitors-based adjuvant therapyAfter surgery, patients who agreed to receive postoperative adjuvant therapy began to undergo immunotherapy when recovered well from the surgery and alanine aminotransferase and aspartate aminotransferase were both less than 80 U/L and total bilirubin was less than 2 mg/dL. Immune checkpoint inhibitors (ICIs) included pembrolizumab, atezolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab. The specific agents of ICIs were determined by the patients' wishes and consultation with their attending physicians. ICIs were injection once every 3 weeks for 12 months and would be terminated when disease progressed or intolerable toxicity occurred. Meanwhile, some patients underwent adjuvant transarterial chemoembolization (TACE) and/or target therapy. | Procedure or surgery | surgery with adjuvant treatment |
| neoadjuvant conversion therapy followed by surgeryPatients were treated preoperatively with a combination of immune checkpoint inhibitors (ICIs), targeted drugs, and locoregional interventions, such as transarterial chemoembolization (TACE) and/or and/or hepatic artery infusion chemotherapy (HAIC).ICIs included pembrolizumab, atezolizumab, tislelizumab, sintilimab, camrelizumab, toripalimab, and durvalumab. Targeted drugs included lenvatinib, bevacizumab, donafenib, sorafenib, regorafenib, and apatinib. The choice of different locoregional therapies and systemic therapy agents for HCC was made by weighing the patient's wishes, cost considerations, and multidisciplinary team (MDT) discussions. ICIs and targeted drugs were used until the disease progressed or an intolerable adverse event occurred. | Procedure or surgery | neoadjuvant conversion surgery group |
| Non-surgeryPatients who received the neoadjuvant conversion therapy but eventually not underwent surgery | Drug | non-surgery |
Primary outcome
overall survival
Time frame: From date of treatment until the date of death from any cause, assessed up to 66 months
2 secondary outcomes
Progression-free survival
Time frame: from the date of the first treatment to the date of tumor progression, assessed up to 66 months
Textbook Outcome in Liver Surgery
Time frame: Within 90 days following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Huge Hepatocellular Carcinoma (HCC) (>10cm), run by Tongji Hospital 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 5 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: finished, as of the sponsor's last update on 10 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: From date of treatment until the date of death from any cause, assessed up to 66 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 10 Jun 2026.