Plasma Sphingolipid Metabolites and Radiotherapy Efficacy in Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNanfang Hospital, Southern Medical University
About this trial
Plasma contains a variety of metabolites, among which sphingolipids, including ceramide, sphingosine, and sphingosine-1-phosphate, serve as important intracellular second messengers and are involved in various cellular signaling pathways, such as apoptosis. We hypothesize that plasma sphingolipid levels may be associated with the efficacy of radiotherapy for liver cancer. This study will utilize LC-MS/MS technology for qualitative and quantitative analysis of plasma sphingolipids in liver cancer patients undergoing radiotherapy. Clinical data related to patient prognosis will also be collected to investigate the correlation between plasma sphingolipid levels and the therapeutic efficacy of liver cancer radiotherapy. The aim is to establish the clinical diagnostic significance of plasma sphingolipid levels in predicting the efficacy of liver cancer radiotherapy, providing new insights to enhance the effectiveness of radiotherapy in liver cancer treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients voluntarily signed the informed consent form.
Aged between 18 and 80 years.
Clinically diagnosed with primary liver cancer according to the latest treatment guidelines.
Determined by the treating physician to require radiotherapy.
Disqualifiers
Patients who discontinued radiotherapy or did not complete the planned treatment.
Presence of malignancies from other origins.
Severe metabolic diseases such as uncontrolled diabetes, significant obesity, or fatty liver disease.
Uncontrolled comorbidities, such as severe cardiovascular or pulmonary diseases, that may affect treatment or study outcomes.
Trial population
This study will enroll adult patients aged 18 to 80 years who have been clinically diagnosed with primary liver cancer according to the latest treatment guidelines. Eligible participants must be determined by their treating physicians to require radiotherapy and have an expected survival time of more than three months. Patients with malignancies of other origins, severe uncontrolled metabolic disorders, or comorbidities that could interfere with treatment outcomes will be excluded.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
260 Participants
are grouped into 2 trial groupsGroup A: Radiotherapy Responder Group
Group B: Radiotherapy Non-Responder Group
Trial outcomes
Primary outcomes
1
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST). mRECIST is commonly used to evaluate tumor response, especially in the context of hepatocellular carcinoma and other solid tumors. DCR is an important measure to assess the overall effectiveness of the treatment in controlling disease progression.
Time frame
From the start of treatment to 12 weeks post-treatment assessmentSecondary outcomes
1
Progression-Free Survival (PFS)
PFS is defined as the time from the start of treatment to disease progression or death from any cause, whichever occurs first, as assessed by mRECIST. This endpoint measures how long patients remain free from tumor progression.
Time frame
From treatment initiation to the date of disease progression or death, up to 24 months.2
Overall Survival (OS)
OS is defined as the time from the start of treatment to death from any cause. This endpoint assesses the overall survival benefit of the treatment.
Time frame
From treatment initiation to death, up to 24 months3
Safety and Tolerability
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) will be evaluated according to CTCAE (Common Terminology Criteria for Adverse Events) version \[specify version\]. This endpoint assesses the safety profile of the
Time frame
From the start of treatment until 90 days after the last dose.Sponsors and contacts
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Source ClinicalTrials.gov