Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Chlorotrianisene

Gao-Jun Teng, M.D.

Hai-Dong Zhu, M.D.

Gao-Jun Teng, MD

Hai-Dong Zhu, MD

The purpose of this study is to id

transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .

Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers

Assessing the Prognosis of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Hepatocellular Carcinoma by Using Clinical and Imaging Biomarkers

The OS is defined as the time from the initiation of any combination treatment to death due to any cause.

The specificity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.

The sensitivity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.

The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.

Defined by a confusion matrix of sensitivity and specificity to true positives and true negatives.

Zhongda Hospital

President

Nivolumab

Pembrolizumab

Atezolizumab

Immune Checkpoint Inhibitors

Tislelizumab

Estrogens

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); ICIs: atezolizumab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, sintilimab or other ICIs

TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE);

TACE plus ICIs ( with or without molecular targeted therapies)

TACE+ICIs

TACE without combination of ICIs ( with or without molecular targeted therapies)

TACE

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) in patients with hepatocellular carcinoma (HCC) .

Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. The purpose of this study is to evaluate the safety and efficacy of TACE in combination with ICIs in patients with HCC. This real-world study also explores the optimal combined treatment and outcome of HCC patients for providing further information for clinical practice and trials.

Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study

Efficacy and Safety of Transarterial Chemoembolization in Combination With Immune Checkpoint Inhibitors for Hepatocellular Carcinoma: a Real-world Study

The PFS is defined as the time from the initiation of any combination treatment to progression according to mRECIST or death from any cause. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).

The OS is defined as the time from the initiation of any combination treatment to death from any cause.

The TTP is defined as the time from the initiation of any combination treatment to progression according to mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm.

The ORR is defined as the proportion of patients with a documented complete response or partial response per mRECIST.

The DCR is defined as the proportion of patients with a documented complete response, partial response, or stable disease according to mRECIST.

Number and degree of the AEs according to CTCAE version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers	NCT05278195	Hepatocellular ...		18 Years -	Zhongda Hospital
Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study	NCT04975932	Hepatocellular ...	TACE+ICIs TACE	18 Years -	Zhongda Hospital
Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers	NCT05278195	Hepatocellular ...		18 Years -	Zhongda Hospital

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