Clinical trial · Observational
HAIC vs. TACE Combined With ICIs and TKIs in Intermediate-to-Advanced HCC: A Multicenter Study on Liver Injury and Survival
NCT07277192CI-TRIAL-00098802completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HAIC(Hepatic Artery Infusion Chemotherapy) | — | UNRESOLVED | — |
| Hepatecellular Carcinoma | — | UNRESOLVED | — |
| Liver Injury | — | UNRESOLVED | — |
| TACE(Transcatheter Arterial Chemoembolization) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- HAIC-group
- description
- HAIC combined with ICIs and TKIs
- label
- TACE-group
- description
- TACE combined with ICIs and TKIs
Primary outcomes (1)
- measure
- 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
Secondary outcomes (4)
- measure
- The median progression free survival time (mPFS)
- timeFrame
- From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 proprietary Chinese medicines; * Patients who do not meet the definition of combination therapy; * Incomplete medical information, such as lack of post-treatment imaging evaluation; * Patients with immunodeficiency or those who have undergone organ/bone marrow transplantation; * Patients deemed unsuitable to participate in this study by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.