An observational study in Unresectable Hepatocellular Carcinom, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Shanghai Zhongshan Hospital · Observational
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 278 is above the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
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Participants are adults (18-75 years) with initially unresectable hepatocellular carcinoma (uHCC) diagnosed by histology/cytology or according to AASLD criteria and Chinese national guidelines. These patients have received conversion therapy consisting of transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After conversion therapy, participants have achieved radiological complete response (rCR) or reached resectability criteria and then either undergo curative liver resection or continue systemic therapy. Eligible patients must have Child-Pugh class A or B liver function and ECOG performance status 0-1.
Exclusion Criteria:
Patients with initially unresectable hepatocellular carcinoma who achieved complete radiological response or resectability after TACE/HAIC + anti-angiogenic agents + immune checkpoint inhibitors and then continued systemic therapy.
Patients with initially unresectable hepatocellular carcinoma who achieved complete radiological response or resectability after TACE/HAIC + anti-angiogenic agents + immune checkpoint inhibitors and then underwent surgical resection.
Event-Free Survival (EFS)
Defined as the time from the date of achieving rCR or resectability criteria to the time of becoming inoperable, recurrence, progression, or death from any cause for uHCC patients.
Time frame: From initiation of post-conversion therapy to the first documented event (recurrence, progression, or death), up to 36 months
2-Year Event-Free Survival (EFS) Rate
Defined as the rate of no events (recurrence, progression, or death from any cause) occurring in rCR patients over 2 years.
Time frame: 2 years after initiation of post-conversion therapy
Overall Survival (OS)
Defined as the survival time from the day of achieving rCR to death from any cause。
Time frame: Up to 36 months after initiation of post-conversion therapy
Treatment Safety
: The incidence of adverse events in the surgery group and the systemic therapy group. Adverse events recorded on the CRF will be mapped to preferred terms using the Medical Dictionary for Regulatory Activities (MedDRA). Severity, seriousness/grade, and the relationship with the study treatment will be assessed by the investigators. The seriousness/grade will be defined according to the National Cancer Institute (NCI) CTCAE v5.0.
Time frame: From initiation of post-conversion therapy through 30 days after last treatment or surgery, up to 36 months follow-up
Cost-Effectiveness of Post-Conversion Treatment Strategies
The cost-effectiveness ratio (C/E) is defined as the ratio of time to an event (EFS) or overall survival (death) from rCR to all direct costs (medical expenses, including outpatient and inpatient), and will be compared between the two groups.
Time frame: Up to 36 months after initiation of post-conversion therapy
No study locations are listed for this record.
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Plan to share: Undecided
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital