Perioperative Risk of Immunotherapy Based Neoadjuvant and Conversion Therapy for Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Participants with hepatocellular carcinoma who have received immunotherapy based neoadjuvant or conversion therapy
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
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.
Time frame
From enrollment to the end of surgery at 4 weeksSecondary outcomes
1
Progression free survival time
The time between the end of surgery and tumor progression ( in any way ) or death ( for any reason )
Time frame
From enrollment to the end of surgery at 12 months2
Overall survival time
The time from the end of surgery to death ( for any reason )
Time frame
From enrollment to the end of surgery at 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov