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
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Sun Yat-sen University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 12-Month PFS Rate (Intention-to-Treat)
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TACE-HAIC+T-B
Transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by toripalimab of 240mg plus bevacizumab (15mg/kg)
Intervention: TACE-HAIC+T-B (Drug)
TACE+T-B
Transartery chemoembolization followed by toripalimab of 240mg plus bevacizumab (15mg/kg)
Intervention: TACE+T-B (Drug)
HAIC+T-B
hepatic artery infusion of FOLFOX regimen followed by toripalimab of 240mg plus bevacizumab (15mg/kg)
Intervention: HAIC+T-B (Drug)
Outcomes
Primary Outcomes
12-Month PFS Rate (Intention-to-Treat)
Time Frame: 12 months
This measure reports the proportion of all randomized patients (ITT population) who are progression-free at 12 months post-randomization.
Secondary Outcomes
- OS(12 months)
- PFS(12 months)
- ORR(12 months)
- adverse event(12 months)
Investigators
Yunfei Yuan
Professor
Sun Yat-sen University