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

Recruiting

• Conditions: Carcinoma, Hepatocellular; Immunotherapy

• Registration Number: NCT06571396
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion Criteria:<br><br>Participants must meet all of the following conditions in order to be enrolled in this<br>study:<br><br> 1. Voluntarily participate in this study and sign an informed consent form.<br><br> 2. Participants diagnosed with HCC through pathological histology/cytology or<br> clinically diagnosed with HCC according to the Diagnosis and Treatment Guidelines<br> for Primary Liver Cancer (2024 Edition).<br><br> 3. Received immunotherapy based neoadjuvant or conversion therapy.<br><br> 4. Complete recovery from surgical resection within 4 weeks prior to enrollment.<br><br> 5. Child Pugh liver function rating A or B (= 7 points).<br><br> 6. ECOG PS score was 0-1 points.<br><br> 7. Expected survival time = 12 weeks.<br><br> 8. If suffering from hepatitis B virus (HBV) infection, it is necessary to be willing<br> to receive antiviral treatment throughout the study period (according to the<br> diagnostic and treatment guidelines, such as entecavir) and regularly monitor it;<br> Hepatitis C virus (HCV) ribonucleic acid (RNA) positive subjects must receive<br> antiviral treatment according to the diagnosis and treatment guidelines, and their<br> liver function must be within CTCAE1 level elevation.<br><br>Exclusion Criteria:<br><br>If a subject meets any of the following conditions, they will not be allowed to enter<br>this study:<br><br> 1. Known hepatobiliary carcinoma, sarcoma like hepatocellular carcinoma, combined<br> hepatocellular-cholangiocarcinoma and fibrous layer cell carcinoma; Within 5 years<br> or simultaneously suffering from other active malignant tumors other than<br> hepatocellular carcinoma (excluding cured skin basal cell carcinoma and cervical<br> carcinoma in situ).<br><br> 2. There are uncontrollable extrahepatic metastases, such as lung and brain metastases<br> (EHS).<br><br> 3. Participants who are preparing to undergo or have previously received organ or<br> allogeneic bone marrow transplantation.<br><br> 4. Participants who are currently accompanied by interstitial pneumonia or interstitial<br> lung disease, or have a history of interstitial pneumonia or interstitial lung<br> disease that requires hormone therapy in the past, other pulmonary fibrosis,<br> organized pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related<br> pneumonia, idiopathic pneumonia, or subjects with evidence of active pneumonia or<br> severe lung function impairment seen on chest computed tomography (CT) images during<br> screening, are allowed to have radiation induced pneumonia in the radiation field;<br> Active tuberculosis<br><br> 5. Currently, there is active autoimmune disease or a history of autoimmune disease<br> that may recur (including but not limited to: autoimmune hepatitis, interstitial<br> pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis,<br> hyperthyroidism, hypothyroidism [subjects that can be controlled only through<br> hormone replacement therapy can be included]); Subjects with skin diseases that do<br> not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled<br> type I diabetes that receive insulin treatment, or childhood asthma that has<br> completely alleviated without any intervention after adulthood can be included;<br> Asthma subjects who require medical intervention with bronchodilators cannot be<br> included.<br><br> 6. Suffering from hypertension and unable to achieve good control through<br> antihypertensive drug treatment (systolic = 140 mmHg or diastolic = 90 mmHg) (based<br> on the average BP reading obtained from = 2 measurements), it is allowed to achieve<br> the above parameters through the use of antihypertensive therapy; Previously<br> experienced hypertensive crisis or hypertensive encephalopathy.<br><br> 7. Participants with moderate to severe ascites with clinical symptoms who require<br> therapeutic puncture or drainage, or whose Child Pugh score is greater than 7<br> (excluding those who only show a small amount of ascites on imaging but do not have<br> clinical symptoms); Uncontrolled or moderate to equal amounts of pleural effusion<br> and pericardial effusion.<br><br> 8. There are clinical symptoms or diseases of the heart that cannot be well controlled,<br> such as: (1) According to the standards of the New York Heart Association (NYHA),<br> level II or above cardiac insufficiency or cardiac ultrasound examination: LVEF<br> (left ventricular ejection fraction)<50%; (2) Unstable angina pectoris; (3) Have<br> experienced myocardial infarction within one year prior to the start of the research<br> treatment; (4) Clinically significant supraventricular or ventricular arrhythmias<br> require treatment or intervention; (5) QTc>480ms (QTc interval is calculated using<br> the Fridericia formula; if QTc is abnormal, it can be detected continuously three<br> times every 2 minutes, and the average value is taken).<br><br> 9. History of spontaneous rupture of liver tumors.<br><br> 10. Individuals with a history of hepatic encephalopathy.<br><br> 11. Congenital or acquired immune dysfunction in subjects (such as HIV infected<br> individuals).<br><br> 12. There have been incidents of thrombosis or embolism occurring within the first 6<br> months of treatment, such as cerebrovascular accidents (including transient ischemic<br> attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.<br><br> 13. Participants with a history of gastrointestinal bleeding or a clear tendency towards<br> gastrointestinal bleeding within 6 months prior to the start of the study treatment,<br> such as those at risk of bleeding or severe esophageal and gastric varices, locally<br> active gastrointestinal ulcer lesions, or continuous positive fecal occult blood,<br> cannot be included in the study. (If fecal occult blood is positive during the<br> baseline period, a follow-up examination is required. If the follow-up examination<br> is still positive, gastroduodenoscopy (EGD) is required. If EGD indicates a risk of<br> bleeding, esophageal and gastric varices/other gastrointestinal diseases cannot be<br> included in the study.)<br><br> 14. Within 6 months prior to the start of treatment, there have been abdominal fistulas,<br> gastrointestinal perforation, or abdominal abscesses.<br><br> 15. Severe, unhealed or cracked wounds, as well as active ulcers or untreated fractures.<br><br> 16. Known genetic or acquired bleeding (such as coagulation dysfunction) or thrombotic<br> tendencies, such as in hemophilia participants; Currently or recently (within 10<br> days prior to the start of research treatment), full dose oral or injection<br> anticoagulants or thrombolytic drugs (prophylactic use of low-dose aspirin, low<br> molecular weight heparin allowed) have been used for therapeutic purposes.<br><br> 17. Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent<br> peripheral arterial thrombosis) occur within 6 months prior to the surgery.<br><br> 18. Severe infection within 4 weeks prior to the surgery, including but not limited to<br> hospitalization due to complications of infection, bacteremia, or severe pneumonia;<br> Oral or intravenous administration of therapeutic antibiotics within 2 weeks prior<br> to the start of the study treatment (subjects who receive prophylactic antibiotics,<br> such as preventing urinary tract infections or exacerbation of chronic obstructive<br> pulmonary disease, are eligible to participate in the study).<br><br> 19. Use immunosuppressive agents or systemic hormone therapy withi

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative risk

Secondary Outcome Measures

Name	Time	Method
Progression free survival time;Overall survival time