A Phase 2 interventional study of TACE-HAIC+T-B and HAIC+T-B in Hepatocellular Carcinoma (HCC), sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
Toripalimab and bevacizumab (T-B) was approve for unresectable hepatocellular carcinoma (uHCC). Transartial therapies, including transarterial chemoembolization (TACE), hepatic artery infusion chemotherapy (HAIC), and TACE-HAIC are commonly used for uHCC. Increasing evidence showed that combined systemic therapy and transarterial therapy will improve the response rate for those patients. It is unknown whether which tranarterial therapy will proved favorable efficiency when combined T-B. This phase 2 clinical trial aims to investigate the short outcome of T-B with three distinct transarterial therapies for uHCC.
Toripalimab in combination with bevacizumab (T-B) has been approved for the treatment of unresectable hepatocellular carcinoma (uHCC). Transarterial therapies-including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), and combined TACE-HAIC-are widely used in the management of uHCC. Growing evidence suggests that combining systemic therapy with transarterial approaches can enhance response rates in these patients. However, it remains unclear which transarterial modality, when used alongside T-B, offers the most favorable efficacy. This phase 2 clinical trial is designed to evaluate and compare the short-term outcomes of T-B in combination with three different transarterial therapies for uHCC.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 90 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by toripalimab of 240mg plus bevacizumab (15mg/kg)
Drug: TACE-HAIC+T-B
Transartery chemoembolization followed by toripalimab of 240mg plus bevacizumab (15mg/kg)
Drug: TACE+T-B
hepatic artery infusion of FOLFOX regimen followed by toripalimab of 240mg plus bevacizumab (15mg/kg)
Drug: HAIC+T-B
Transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by toripalimab of 240mg plus bevacizumab (15mg/kg)
FOLFOX-based HAIC regimen followed by toripalimab of 240mg plus bevacizumab
TACE was performed using 30 mg/m2 of epirubicin, 300mg/m2 carb mixed with 2-5 mL lipiodol, followed by pure lipiodol, followed by toripalimab was adminstated at 240mg and bevacizumab was adminstated at 15mg/kg.
12-Month PFS Rate (Intention-to-Treat)
This measure reports the proportion of all randomized patients (ITT population) who are progression-free at 12 months post-randomization.
Time frame: 12 months
OS
overall survival time after randomisation, taking into account all deaths
Time frame: 12 months
PFS
progression free survival time after randomisation, taking into account all deaths
Time frame: 12 months
ORR
objective response rate assessed by RECIST 1.1
Time frame: 12 months
adverse event
adverse event was assessed by NCI-CTC 5.0 to evaluate safety
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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