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Completed

NCT Number: NCT04975932

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

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) .

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with HCC by radiology, histology, or cytology;
  • patients who underwent TACE combined with ICIs therapies ( with or without molecular targeted therapies) were included in the study group. For patients in the study group, ICIs therapies were received before the TACE or within 2 months after TACE and at least one cycle of immunotherapy has been received;
  • during the same period, patients who underwent TACE without the combination of ICIs therapies ( with or without molecular targeted therapies) were included into the control group;
  • patients who underwent TACE combined with ICIs therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with TACE or immunotherapy.

Exclusion criteria

  • exceeding the time interval of the combination therapy defined above;
  • missing follow-up data;

Treatment and study plan

TACE+ICIs

Other

TACE plus ICIs ( with or without molecular targeted therapies)

TACE

Procedure

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

Primary outcomes

  1. Progression free survival(PFS)

    Time frame: up to approximately 1 years

    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).

Secondary outcomes

  1. Overall survival(OS)

    Time frame: up to approximately 2 years

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

  2. Time to Progression(TTP)

    Time frame: up to approximately 1 years

    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.

  3. Objective response rate(ORR)

    Time frame: 6-8 week after TACE

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

  4. Disease control rate(DCR)

    Time frame: 6-8 week after TACE

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

  5. Adverse event(AE)

    Time frame: baseline to end of study (approximately 2 years)

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

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

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

Acronym: CHANCE001

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 26, 2021
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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