Hepatocellular Carcinoma (HCC)
Conditions
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.
Interventions
DRUGTACE-HAIC+T-B
Transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by toripalimab of 240mg plus bevacizumab (15mg/kg)
DRUGHAIC+T-B
FOLFOX-based HAIC regimen followed by toripalimab of 240mg plus bevacizumab
DRUGTACE+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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-Month PFS Rate (Intention-to-Treat) | 12 months | This measure reports the proportion of all randomized patients (ITT population) who are progression-free at 12 months post-randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 12 months | overall survival time after randomisation, taking into account all deaths |
| PFS | 12 months | progression free survival time after randomisation, taking into account all deaths |
| ORR | 12 months | objective response rate assessed by RECIST 1.1 |
| adverse event | 12 months | adverse event was assessed by NCI-CTC 5.0 to evaluate safety |
Countries
China
Outcome results
None listed