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NCT06818097Completed

Efficacy of Target - Immunotherapy and XELOX Chemotherapy for Advanced HCC

Efficacy Analysis of the Combined Target - Immunotherapy and XELOX Chemotherapy Regimen in the Treatment of Advanced Hepatocellular Carcinoma.

Source: ClinicalTrials.gov · Last updated 20 May 2025

Brief summary (registry, in English)

In China, primary hepatocellular carcinoma (HCC) has high morbidity and mortality, imposing a heavy burden on the public. Surgical resection is an effective treatment, but as HCC is often latent, less than 30% of patients are suitable for surgery at first diagnosis. So systemic anti-tumor therapy is crucial for advanced HCC. Small-molecule targeted drugs like lenvatinib and sorafenib are NCCN-recommended first-line drugs for advanced HCC. The combination of targeted drugs and immune checkpoint inhibitors can prolong overall survival with good safety. The "2024 Guidelines for HCC Diagnosis and Treatment" shows that platinum-containing chemotherapy is a preferred systemic treatment for advanced HCC. However, in real-world practice, the efficacy and safety of the combination of targeted-immunotherapy and chemotherapy regimen for advanced HCC remain unclear.

Status (registry)
Completed
Study type
Observational
Enrollment
68 (actual)
First submitted
16 Jan 2025
Start date
1 Oct 2021
Primary completion date
1 Apr 2025
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NCT number
NCT06818097

What you commit to

  • Study type: Observational
  • Participants enrolled: 68
  • From 1 Oct 2021 to the primary completion date, 1 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Experienced rupture and bleeding of esophageal or gastric varices within the past six months.
  • Imaging examinations reveal cardiac involvement in hepatocellular carcinoma.

Other

  • Imaging findings indicate the presence of main portal vein invasion in hepatocellular carcinoma.
  • Imaging results show inferior vena cava involvement in hepatocellular carcinoma.
  • Pregnancy and lactation.

Who the study is looking for

  • Be aged 18 years or older and be diagnosed with HCC by histology, cytology, or imaging studies.
  • Have HCC with a clinical stage corresponding to Barcelona Clinic Liver Cancer (BCLC) stage C.
  • Have not undergone systemic treatment previously, and initially receive the targeted - immunotherapy combined with XELOX chemotherapy regimen (lenvatinib + Sintilimab or Camrelizumab or Tislelizumab + Capecitabine + Oxaliplatin) upon the diagnosis of HCC.
  • Have a liver function classified as Child - Pugh grade A or B.
  • Have an ECOG PS score of 0 or 1.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Sen Memorial Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.