Study on the Classification of Comprehensive Treatment Effect of Hepatocellular Carcinoma

NCT06542796 | Recruiting

• 1 other identifier: 2024-0318
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Through a retrospective study of patients who underwent comprehensive treatment for hepatocellular carcinoma at the Second Affiliated Hospital of Zhejiang University, we explored the risk factors related to the sensitivity of comprehensive treatment. We used the PD-L1 expression level of patients before comprehensive treatment，characteristic morphology of tertiary lymphoid structures, as well as other parameters, are used to construct a liver cancer comprehensive treatment efficacy evaluation model. Using this liver cancer comprehensive treatment efficacy evaluation model, we conducted a randomized controlled trial on whether to receive comprehensive treatment for liver cancer patients to verify the accuracy and practical value of the model.

Conditions

Hepatocellular Carcinoma; Immunotherapy

Keywords

Tertiary Lymphoid Structures; Vascular Endothelial Growth Factor A; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Evaluation of the efficacy of patient treatment

  The treatment effects were assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) proposed by the American Cancer Institute. The treatment effects were divided into complete remission (CR), partial remission (PR), stable disease (SD), progressive disease (PD), objective response rate (ORR) = CR + PR, and disease control rate (DCR) = CR + PR + SD. All the data in this study were analyzed and processed with statistical software SPSS 24.0. The measurement data were expressed in mean ± SD (±s). When the measurement data conform to the normal distribution and the variance was homogeneous, a t-test was adopted. The counting data were described by N and %. The disordered classification data were compared by the χ2 test or Fisher's exact probability method. All tests were two-sided, and the difference was statistically significant when P \< 0.05.

  Long-term follow-up of patients after treatment through the study completion, an average of 1 year

• The predictive accuracy of the constructed model

  The predictive accuracy of the constructed model was determined by measuring the specificity, sensitivity, and area under the receiver operating characteristic (ROC) curve in the validation sample. Discrimination refers to the ability of a predictive model to accurately identify patients at low and high risk for the event under investigation, usually expressed as the area under the ROC curve. A predictive model with an ROC of 0·75 is considered to have good discrimination, whereas an area of 0·5 is considered equivalent to a coin toss.All the data in this study were analyzed and processed with statistical software SPSS 24.0. All tests were two-sided, and the difference was statistically significant when P \< 0.05.

  Long-term follow-up of patients after treatment through the study completion, an average of 1 year

Study Arms (2)

Comprehensive treatment group

EXPERIMENTAL

Immunotherapy combined with targeted therapy

Procedure: Immunotherapy combined with targeted therapy

non-comprehensive treatment group

ACTIVE COMPARATOR

Standard treatment plan

Other: Standard treatment plan

Interventions

Immunotherapy combined with targeted therapy PROCEDURE

Immunotherapy combined with targeted therapy

Comprehensive treatment group

Standard treatment plan OTHER

Standard treatment plan

non-comprehensive treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced hepatocellular carcinoma

You may not qualify if:

• Have comorbidities of severe diabetes, heart failure, liver and/or kidney failure
• Have a history of schizophrenia
• Have a history of other malignant tumors or metastatic liver tumors discovered after surgery
• Received anti-tumor drugs for other diseases
• Special groups such as pregnant and lactating women.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Tertiary Lymphoid Structures

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: August 7, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 10, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)