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NCT05660213Not yet recruiting

A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer

A Multicenter Registry Study on the Efficacy and Safety of Different Treatment Regimens for Unresectable CNLC Liver Cancer Stage III Hepatocellular Carcinoma

Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study is a multicenter, registered research aimed at evaluating the efficacy of different treatment regimens in the treatment of unresectable CNLC liver cancer stage III hepatocellular carcinoma

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
750 (estimated)
First submitted
13 Dec 2022
Start date
1 Aug 2025
Primary completion date
31 Aug 2027
Lead sponsor
Fudan University
NCT number
NCT05660213

What you commit to

  • Study type: Observational
  • Planned participants: 750
  • From 1 Aug 2025 to the primary completion date, 31 Aug 2027
  • No sites listed in no 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.

Prior treatment

  • Received radiation therapy within the past 4 weeks;

Other illness

  • Simultaneously having two or more active primary malignant tumors;
  • Portal vein cancer thrombus invades the superior mesenteric vein;

Lab values

  • Coagulation dysfunction (INR\>2.0, PT\>16 s) or diseases with a strong likelihood of bleeding (including but not limited to esophageal and/or gastric variceal bleeding, active ulcers, uncontrolled hypertension);

Other

  • Expected survival time is less than 3 months;
  • Pregnant or lactating women or those planning to conceive;
  • Refusing to cooperate with follow-up visits;
  • Other reasons led the researchers to believe that it was not suitable to participate in this study.

Who the study is looking for

  • ·≥ 18 years old;
  • Diagnosed as unresectable hepatocellular carcinoma through histopathological and/or cytological examination, or meeting the clinical diagnostic criteria for hepatocellular carcinoma in the 2022 edition of the guidelines for the diagnosis and treatment of primary liver cancer;
  • CNLC liver cancer stage III;
  • Liver function Child Pugh A or B grade 7 points;
  • Has not received systematic treatment in the past;
  • Patients with active HBV infection who meet one of the following conditions can be enrolled: ① Within 28 days before enrollment, the patient's HBV DNA is less than 500 IU/mL. If they have received anti HBV treatment, they need to continue their original antiviral treatment; If anti HBV treatment has not been received, it is necessary to receive anti HBV treatment throughout the entire course of medication (according to local treatment standards; for example, entecavir); ② For patients with HBV DNA\>500 IU/mL and who have not received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Before enrollment, the serum HBV-DNA virus should be retested to decrease by more than 1 log value For patients with HBV DNA\>500 IU/mL and who have received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Serum HBV-DNA virus levels should be retested before enrollment;
  • Active HCV infected individuals with stable disease status after treatment;
  • At least one tumor lesion available for evaluation;
  • Clear consciousness, language expression ability or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation;
  • Voluntarily join this study and sign an informed consent form.

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

Full criteria on ClinicalTrials.gov

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