Actively Recruiting

Age: 18Years - 80Years
All Genders
ID06864221

Correlation Between Plasma Sphingolipid Metabolites and the Efficacy of Radiotherapy in Hepatocellular Carcinoma

Led by Nanfang Hospital, Southern Medical University · Updated on 2025-03-12

260

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore the relationship between plasma sphingolipid levels and the effectiveness of radiotherapy in patients with primary liver cancer, specifically hepatocellular carcinoma. The study focuses on key metabolites like ceramide, sphingosine, and sphingosine-1-phosphate, which play roles in cell signaling and apoptosis. Researchers hypothesize that these sphingolipid levels may predict how well radiotherapy works, helping to improve treatment strategies for liver cancer. The study is a single-center, prospective observational project involving 260 patients undergoing radiotherapy for liver cancer. Plasma samples will be collected before, during, and after treatment to analyze sphingolipid metabolites using advanced mass spectrometry techniques. Patients will be grouped based on their response to radiotherapy, classified by imaging criteria into responders and non-responders. The study also monitors radiation-induced side effects such as liver disease, enteritis, and bone marrow suppression. Participants will be followed for up to four years after radiotherapy, with assessments at multiple time points including 1, 2, 6, 12, 18, 24, 36, and 48 months. Clinical imaging, laboratory tests, and adverse event monitoring will be performed to correlate sphingolipid levels with treatment outcomes and safety. The main outcome measure is the disease control rate assessed 12 weeks post-treatment, with additional measures including progression-free survival, overall survival, and treatment tolerability.

CONDITIONS

Brief Title

Plasma Sphingolipid Metabolites and Radiotherapy Efficacy in Hepatocellular Carcinoma

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
  • Expected survival time of more than 3 months.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Radiotherapy period plus up to 12 weeks post-treatment

Participants receiving radiotherapy are observed with plasma samples collected before, during, and after radiotherapy to analyze sphingolipid metabolites. Clinical imaging and laboratory data related to treatment response and adverse events are also collected.

Multiple visits corresponding to radiotherapy sessions and up to 12 weeks post-treatment assessments

Long-term Monitoring

Duration - Up to 48 months post-radiotherapy

Participants are followed for up to 48 months after radiotherapy to assess survival, disease progression, and late treatment-related toxicity including radiation-induced liver disease and other adverse effects.

Visits at 1, 2, 6, 12, 18, 24, 36, and 48 months post-radiotherapy

Trial Site Locations

Total: 1 location

1

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

Loading map...

Research Team

Y

Yiyi Li, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

Clinical Impact of 18F-FDGal PET/CT and PET/MRI in Patients ...

Hepatocellular Carcinoma

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Ionizing radiations increase the activity of the cell surface glycohydrolases and the plasma membrane ceramide content.

Massimo Aureli, Rosaria Bassi, Alessandro Prinetti...

https://pubmed.ncbi.nlm.nih.gov/22592846

The clinical management of hepatocellular carcinoma worldwide: A concise review and comparison of current guidelines: 2022 update.

Ningyuan Wen, Yulong Cai, Fuyu Li...

https://pubmed.ncbi.nlm.nih.gov/35197399