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

NCT07380633 | Active Not Recruiting Phase 2

• 1 other identifier: B2025-900-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• OS

  12 months

• PFS

  12 months

• ORR

  12 months

• adverse event

  12 months

Study Arms (3)

TACE-HAIC+T-B

EXPERIMENTAL

Transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by toripalimab of 240mg plus bevacizumab (15mg/kg)

Drug: TACE-HAIC+T-B

TACE+T-B

ACTIVE COMPARATOR

Transartery chemoembolization followed by toripalimab of 240mg plus bevacizumab (15mg/kg)

Drug: TACE+T-B

HAIC+T-B

ACTIVE COMPARATOR

hepatic artery infusion of FOLFOX regimen followed by toripalimab of 240mg plus bevacizumab (15mg/kg)

Drug: HAIC+T-B

Interventions

TACE-HAIC+T-B DRUG

Transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by toripalimab of 240mg plus bevacizumab (15mg/kg)

TACE-HAIC+T-B

HAIC+T-B DRUG

FOLFOX-based HAIC regimen followed by toripalimab of 240mg plus bevacizumab

HAIC+T-B

TACE+T-B DRUG

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.

TACE+T-B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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);

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The TACE was performed using 30 mg/m2 of epirubicin, 300mg/m2 carb mixed with 2-5 mL lipiodol, followed by pure lipiodol. The HAIC regimen at the following dosage: 85 mg/m2 of oxaliplatin infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; 400 mg/m2 of 5-FU bolus; and 1200mg/m2 of continuous 5-FU infusion for 23 hours, respectively. TACE-HAIC was performed TACE following by HAIC. Repeated transarterial therapy was performed at intervals of 3-4 weeks. Toripalimab was adminstated at 240mg and bevacizumab was adminstated at 15mg/kg on next day after transarterial therapy.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: January 23, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)