HAIC vs. TACE Combined With ICIs and TKIs in Intermediate-to-Advanced HCC: A Multicenter Study on… (NCT07277192) | Clinical Trial Compass
CompletedNot Applicable
HAIC vs. TACE Combined With ICIs and TKIs in Intermediate-to-Advanced HCC: A Multicenter Study on Liver Injury and Survival
China562 participantsStarted 2023-10-01
Plain-language summary
The purpose of this study is to compare the liver injury induced by HAIC combined with PD-1/PD-L1 inhibitors and TKIs versus triple therapy with TACE in the treatment of patients with advanced HCC; to compare the efficacy of the two triple therapy regimens in the treatment of patients with advanced HCC.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients voluntarily join this study and sign the informed consent form;
* Aged ≥ 18 years, both male and female;
* Patients with pathologically or clinically confirmed BCLC stage B or C hepatocellular carcinoma (HCC) who were diagnosed between January 1, 2019, and December 31, 2022;
* Receiving treatment with PD-1/PD-L1 inhibitors combined with anti-angiogenic drugs (both PD-1/PD-L1 inhibitors and targeted drugs are only approved post-market medications, including but not limited to those with HCC indications);
* Transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) completed within 3 months after the first systemic treatment or within 1 month before the first systemic treatment;
* Having at least one measurable intrahepatic lesion, with intrahepatic lesions being the main tumor burden. (According to RECIST v1.1, the measurable lesion has a spiral CT scan long diameter ≥ 10 mm or enlarged lymph node short diameter ≥ 15 mm).
Exclusion Criteria:
* Pathologically/histologically confirmed cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma;
* Patients with a history of other malignant tumors within the past 3 years or concurrent malignant tumors (except cured basal cell carcinoma of the skin and cervical in situ carcinoma);
* Concomitant use of other antitumor therapeutic agents, such as antitumor traditional Chinese medicines and…
What they're measuring
1
alanine aminotransferase(ALT)
Timeframe: Measurements were conducted one week before the first treatment and at regular intervals for up to six months after the intervention, continuing until the occurrence of unacceptable toxicity, withdrawal of consent, or termination of the study by the spon
Trial details
NCT IDNCT07277192
SponsorNanfang Hospital, Southern Medical University