Conversion Therapy Using TACE/HAIC With Anti-Angiogenic and Immunotherapy for Initially Unresecta… (NCT07206511) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Conversion Therapy Using TACE/HAIC With Anti-Angiogenic and Immunotherapy for Initially Unresectable Hepatocellular Carcinoma Achieving Complete Response or Resectability, Followed by Surgery or Continued Systemic Treatment: A Prospective Cohort Study
278 participantsStarted 2025-10-09
Plain-language summary
This is a prospective cohort study designed to evaluate the effectiveness and safety of two post-conversion treatment strategies for patients with initially unresectable hepatocellular carcinoma (uHCC). Participants first receive conversion therapy with transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After this therapy, patients who achieve complete radiological response (rCR) or meet resectability criteria will either undergo surgical resection or continue systemic therapy. The study aims to compare outcomes between these two strategies to help guide treatment decisions for advanced liver cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent.
✓. Age 18-75 years.
✓. Hepatocellular carcinoma (HCC) confirmed by histology/cytology or diagnosed according to the AASLD criteria.
✓. Initially unresectable HCC (uHCC), defined according to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition) and the Chinese Expert Consensus on Conversion and Perioperative Therapy for Primary Liver Cancer (2024 edition): HCC considered unsafe for curative resection due to inability to ensure both oncological completeness (R0 resection) and functional hepatic reserve (adequate future liver remnant with good vascular supply and biliary drainage to maintain postoperative liver function and minimize morbidity and mortality). Mainly includes CNLC stage Ib-IIIa or potentially resectable cases. Some stage Ia patients may also be considered uHCC if the tumor is adjacent to major intrahepatic vessels or involves the first/second hepatic hilum making R0 resection infeasible, or if severe cirrhosis increases risk of postoperative liver failure and complications; these can be considered after successful conversion and supportive treatment.
✓. No prior systemic therapy before conversion treatment.
✓. Conversion therapy regimen must include TACE or HAIC plus anti-angiogenic agents and immune checkpoint inhibitors (ICIs).
✓. Anti-angiogenic agents may include lenvatinib, sorafenib, apatinib, donafenib, anlotinib, bevacizumab.
What they're measuring
1
Event-Free Survival (EFS)
Timeframe: From initiation of post-conversion therapy to the first documented event (recurrence, progression, or death), up to 36 months