Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06542796

Study on the Classification of Comprehensive Treatment Effect of Hepatocellular Carcinoma

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effectiveness of a new model to evaluate comprehensive treatment for hepatocellular carcinoma (HCC), a common and deadly liver cancer. The model uses factors like PD-L1 expression, tertiary lymphoid structures (TLS), and vascular endothelial growth factor (VEGF) levels to predict treatment outcomes. This study aims to help classify patients accurately and guide treatment decisions by comparing comprehensive therapy involving immunotherapy and targeted therapy to standard treatment plans. Participants will be randomly assigned to one of two groups: one receiving immunotherapy combined with targeted therapy, and the other receiving the standard treatment plan. The study will assess the efficacy of these approaches using the constructed predictive model. This randomized controlled trial is based on prior retrospective analysis and intends to validate the model's accuracy and practical use. During the study, patients will be followed for about one year after treatment to evaluate treatment effectiveness and the predictive accuracy of the model. Researchers will monitor long-term outcomes and use measures like sensitivity, specificity, and the area under the receiver operating characteristic (ROC) curve to assess the model's performance. This follow-up will help determine how well the model predicts patient responses to comprehensive treatment for liver cancer.

CONDITIONS

Brief Title

Study on the Classification of Comprehensive Treatment Effect of Hepatocellular Carcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with advanced hepatocellular carcinoma
  • Aged between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Severe diabetes, heart failure, liver or kidney failure
  • History of schizophrenia
  • History of other malignant tumors or metastatic liver tumors discovered after surgery
  • Received anti-tumor drugs for other diseases
  • Pregnant or lactating women

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of treatment as per assigned treatment plan

Participants receive either immunotherapy combined with targeted therapy or a standard treatment plan for advanced hepatocellular carcinoma.

Visit schedule depends on treatment assignment

Follow-up

Duration - Approximately 1 year

Participants are followed long-term after treatment to evaluate treatment efficacy and the predictive accuracy of the treatment efficacy model.

Regular follow-up visits during the 1-year period

Trial Site Locations

Total: 1 location

1

2ndAffiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310009

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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