Toripalimab Plus Bevacizumab Combined Three Intra-arterial Therapies (TACE, HAIC, or TACE-HAIC) for Unresectable Hepatocellular Carcinoma: a Phase 2, Multicenter Randomised Non-comparative Trial

Toripalimab Plus Bevacizumab Combined Three Intra-arterial Therapies (Transarterial Chemoembolization, Hepatic Artery Infusion Chemotherapy, or Transarterial Chemoembolization Plus Hepatic Artery Infusion Chemotherapy) for Unresectable Hepatocellular Carcinoma: a Phase 2, Multicenter Randomised Non-comparative Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Drug: TACE-HAIC+T-B; Drug: TACE+T-B; Drug: HAIC+T-B

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Sun yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (a) patients were diagnozied with unresectable HCC, (b) Child-Pugh A or B liver function; (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1; (e) adequate hematologic blood counts (white blood cell count >3ⅹ109/L, absolute neutrophil count >1.5ⅹ109/L, platelet count >10ⅹ109/L, hemoglobin concentration >85 g/L);

Exclusion Criteria:

• (a) severe underlying cardiac, pulmonary, or renal diseases; (b) history of a second primary malignant tumor; (c) contraindication to either toripalimab and bevacizumab.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TACE-HAIC+T-B; 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 and hepatic artery infusion of FOLFOX, simultaneously followed by toripalimab of 240mg plus bevacizumab (15mg/kg)
Active Comparator: TACE+T-B; Transartery chemoembolization followed by toripalimab of 240mg plus bevacizumab (15mg/kg)	Drug: TACE+T-B; 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.
Active Comparator: HAIC+T-B; hepatic artery infusion of FOLFOX regimen followed by toripalimab of 240mg plus bevacizumab (15mg/kg)	Drug: HAIC+T-B; FOLFOX-based HAIC regimen followed by toripalimab of 240mg plus bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival time after randomisation, taking into account all deaths	12 months
PFS	progression free survival time after randomisation, taking into account all deaths	12 months
ORR	objective response rate assessed by RECIST 1.1	12 months
adverse event	adverse event was assessed by NCI-CTC 5.0 to evaluate safety	12 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: B2025-900-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No