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Carcinoma, HepatocellularNCT06571396

Perioperative Risk of Immunotherapy Based Neoadjuvant and Conversion Therapy for Hepatocellular Carcinoma

An observational study of Carcinoma, Hepatocellular and Immunotherapy, run by Qilu Hospital of Shandong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to retrospectively collect a cohort of participants with hepatocellular carcinoma who received immunotherapy-based neoadjuvant/translational treatment. A multi-dimensional and multi-method analysis plan will be adopted. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular, Immunotherapy
How many people
200 participants
Where
1 siteChina
Study dates
1 Apr 2014to 3 Aug 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with hepatocellular carcinoma who have received immunotherapy based neoadjuvant or conversion therapy

Who may be able to join

  • Participants must meet all of the following conditions in order to be enrolled in this study:
  • Voluntarily participate in this study and sign an informed consent form.
  • Participants diagnosed with HCC through pathological histology/cytology or clinically diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition).
  • Received immunotherapy based neoadjuvant or conversion therapy.
  • Complete recovery from surgical resection within 4 weeks prior to enrollment.
  • Child Pugh liver function rating A or B (≤ 7 points).
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  • ECOG PS score was 0-1 points.
  • Expected survival time ≥ 12 weeks.
  • If suffering from hepatitis B virus (HBV) infection, it is necessary to be willing to receive antiviral treatment throughout the study period (according to the diagnostic and treatment guidelines, such as entecavir) and regularly monitor it; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive subjects must receive antiviral treatment according to the diagnosis and treatment guidelines, and their liver function must be within CTCAE1 level elevation.

Who cannot join

  • If a subject meets any of the following conditions, they will not be allowed to enter this study:
  • Known hepatobiliary carcinoma, sarcoma like hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma and fibrous layer cell carcinoma; Within 5 years or simultaneously suffering from other active malignant tumors other than hepatocellular carcinoma (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
  • There are uncontrollable extrahepatic metastases, such as lung and brain metastases (EHS).
  • Participants who are preparing to undergo or have previously received organ or allogeneic bone marrow transplantation.
  • Participants who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy in the past, other pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with evidence of active pneumonia or severe lung function impairment seen on chest computed tomography (CT) images during screening, are allowed to have radiation induced pneumonia in the radiation field; Active tuberculosis
  • Currently, there is active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can be controlled only through hormone replacement therapy can be included]); Subjects with skin diseases that do not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma subjects who require medical intervention with bronchodilators cannot be included.
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  • Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) (based on the average BP reading obtained from ≥ 2 measurements), it is allowed to achieve the above parameters through the use of antihypertensive therapy; Previously experienced hypertensive crisis or hypertensive encephalopathy.
  • Participants with moderate to severe ascites with clinical symptoms who require therapeutic puncture or drainage, or whose Child Pugh score is greater than 7 (excluding those who only show a small amount of ascites on imaging but do not have clinical symptoms); Uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.
  • There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) According to the standards of the New York Heart Association (NYHA), level II or above cardiac insufficiency or cardiac ultrasound examination: LVEF (left ventricular ejection fraction)<50%; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year prior to the start of the research treatment; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; (5) QTc>480ms (QTc interval is calculated using the Fridericia formula; if QTc is abnormal, it can be detected continuously three times every 2 minutes, and the average value is taken).
  • History of spontaneous rupture of liver tumors.
  • Individuals with a history of hepatic encephalopathy.
  • Congenital or acquired immune dysfunction in subjects (such as HIV infected individuals).
  • There have been incidents of thrombosis or embolism occurring within the first 6 months of treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
  • Participants with a history of gastrointestinal bleeding or a clear tendency towards gastrointestinal bleeding within 6 months prior to the start of the study treatment, such as those at risk of bleeding or severe esophageal and gastric varices, locally active gastrointestinal ulcer lesions, or continuous positive fecal occult blood, cannot be included in the study. (If fecal occult blood is positive during the baseline period, a follow-up examination is required. If the follow-up examination is still positive, gastroduodenoscopy (EGD) is required. If EGD indicates a risk of bleeding, esophageal and gastric varices/other gastrointestinal diseases cannot be included in the study.)
  • Within 6 months prior to the start of treatment, there have been abdominal fistulas, gastrointestinal perforation, or abdominal abscesses.
  • Severe, unhealed or cracked wounds, as well as active ulcers or untreated fractures.
  • Known genetic or acquired bleeding (such as coagulation dysfunction) or thrombotic tendencies, such as in hemophilia participants; Currently or recently (within 10 days prior to the start of research treatment), full dose oral or injection anticoagulants or thrombolytic drugs (prophylactic use of low-dose aspirin, low molecular weight heparin allowed) have been used for therapeutic purposes.
  • Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occur within 6 months prior to the surgery.
  • Severe infection within 4 weeks prior to the surgery, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia; Oral or intravenous administration of therapeutic antibiotics within 2 weeks prior to the start of the study treatment (subjects who receive prophylactic antibiotics, such as preventing urinary tract infections or exacerbation of chronic obstructive pulmonary disease, are eligible to participate in the study).
  • Use immunosuppressive agents or systemic hormone therapy within 14 days prior to the surgery to achieve immunosuppressive effects (dose>10mg/day prednisone or other therapeutic hormones).
  • Received attenuated live vaccine treatment within 28 days prior to the surgery.
  • According to the judgment of the researchers, the subjects may have other factors that may affect the research results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious illnesses (including mental illness) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that may affect the safety of the subjects.

Trial locations and contacts

1 site in 1 country.

Tao Li contact

18560085138

litao7706@163.com

China1 site, 1 recruiting

  • Qilu hospital of Shandong university

    Jinan, Shandong, 250012

    Tao Li, 18560085138, litao7706@163.com

    Recruiting

Other trials in China

About this study

Official title: Perioperative Risk Factors and Nomograms for Participants With Hepatocellular Carcinoma Receiving Neoadjuvant Immunotherapy or Conversion Therapy

This study aims to retrospectively collect a cohort of participants with hepatocellular carcinoma who received immunotherapy-based neoadjuvant/translational treatment. A multi-dimensional and multi-method analysis plan will be adopted. The goal is to provide solutions for better application of neoadjuvant immunotherapy and to offer better evidence for conducting prospective clinical research on hepatocellular carcinoma.

Read the detailed description

Hepatocellular carcinoma (HCC) is indeed a significant health concern, especially in regions like China where its incidence and mortality rates are notably high. Radical resection is the main method for curing HCC. However, about 64% of HCC participants are diagnosed at mid to late stages, making surgical resection unsuitable as the first choice. Additionally, the short-term recurrence rate after HCC surgery is relatively high, with a five-year recurrence and metastasis rate reaching 70%. Therefore, increasing the radical resection rate and reducing the postoperative recurrence rate are key measures to improve prognosis.

With the development of tumor genomics and immunology, systematic treatment based on immune checkpoint inhibitors (ICIs) has shown remarkable efficacy in improving HCC prognosis. The application of ICIs in perioperative treatment of solid tumors can effectively reduce tumor burden while expanding the immune effect of tumor antigens, thereby increasing resection rates and reducing recurrence rates.

Currently, neoadjuvant immunotherapy has achieved good treatment outcomes in lung cancer, esophageal cancer, and gastric cancer. However, the increased antitumor treatment may lead to potential treatment side effects. For neoadjuvant immunotherapy in solid tumors, preoperative treatment can pose perioperative risks such as tissue edema, adhesions, and excessive bleeding during surgery. Due to the hidden effects of some immune therapy adverse reactions, these perioperative risks require particular attention and research.

Neoadjuvant immunotherapy for HCC is still in its infancy, with a limited number of cases reported by various centers, and there are currently no large-sample clinical studies available.

The investigators intend to establish a cohort of HCC participants undergoing neoadjuvant/conversion treatment. It will employ a multidimensional and multi-method analysis plan to systematically investigate the perioperative risks associated with immunotherapy in these participants, aiming to provide solutions for better application of neoadjuvant immunotherapy in HCC, while also offering improved evidence for the conduct of prospective clinical research in HCC.

Medical subject headings
Carcinoma, Hepatocellular

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative risk

    The criteria for perioperative risk include four aspects: operation time, transfusion, postoperative hospital stay, and complication. Operation time >200min is counted as 3 points, transfusion is counted as 2 points, postoperative hospital stay >8 days is counted as 2 points, and complication is counted as 1 point. The total score range is 0-8 points. Participants with a score of 3 or lower are considered to have a low perioperative risk, while those above 3 are considered to have a high perioperative risk.

    Measured: From enrollment to the end of surgery at 4 weeks

Secondary outcomes (2)

  1. Progression free survival time

    The time between the end of surgery and tumor progression ( in any way ) or death ( for any reason )

    Measured: From enrollment to the end of surgery at 12 months

  2. Overall survival time

    The time from the end of surgery to death ( for any reason )

    Measured: From enrollment to the end of surgery at 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start1 Apr 2014
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion3 Aug 2026 (estimated)

Resources

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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571396
Sponsor's protocol ID
KYLL-2024(ZM)-1324
Status last verified
Aug 2024
First submitted
22 Aug 2024
Last updated
26 Aug 2024
Results posted
No

Publications

  • Peng S, Liu C, Long J, Tian J, Li H, Lu D, Cao Q, Zhang D, He Q, Jia J, Wang Y, Dong Z, Zhao H, Zhao L, Wang D, Li T. Integrated single-cell multi-omics characterization reveals lipid-associated macrophage-mediated immunosuppression in neoadjuvant immunotherapy of hepatocellular carcinoma. Nat Commun. 2026 Jul 31;17(1):9381. doi: 10.1038/s41467-026-75949-y.

    PubMed 42680737

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Hepatocellular and Immunotherapy, run by Qilu Hospital of Shandong 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 9 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tao Li (18560085138, litao7706@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative risk (time frame: From enrollment to the end of surgery at 4 weeks). 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 NCT06571396, 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 2024.

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