CompletedNot Applicable

TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Intermediate HCC

China941 participantsStarted 2022-12-28

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with PD-1/PD-L1 Inhibitors and molecular target therapies in patients with Intermediate-stage hepatocellular carcinoma (HCC).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
✓. Barcelona Clinic Liver Cancer (BCLC) stage B, without the presence of extrahepatic spread and/or macrovascular invasion;
✓. Has not received any previous TACE/HAIC and systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
✓. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
✓. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment;
✓. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
✓. Has repeated measurable intrahepatic lesions according to mRECIST;

Exclusion criteria

✕. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
✕. Unable to meet criteria of combination timeframe described above;

What they're measuring

Progression free survival(PFS) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

Timeframe: up to approximately 2 years

Overall Survival(OS)

Timeframe: up to approximately 2 years

Trial details

NCT IDNCT05332496

SponsorZhongda Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-30

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials