NCT05621499

HAIC or Lenvatinib Combined With Sintilimab for High Recurrence Risk Resectable Solitary Hepatocellular Carcinoma

The Safety and Efficacy of HAIC or Lenvatinib Combined With Sintilimab as a Neoadjuvant Therapy for High Recurrence Risk Resectable Stage IB Solitary Hepatocellular Carcinoma: a Prospective, Randomized, Two Cohort, Exploratory Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of HAIC or Lenvatinib combined with Sintilimab as a neoadjuvant therapy for high recurrence risk resectable stage IB solitary hepatocellular carcinoma

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	HAIC	Oxaliplatin 85 mg/m2, LV 400 mg/ m2, 5-FU 400 mg/m2 bolus and then 2400 mg/m2 as 46h continuous infusion，Q3W，a total of 2 cycles
DRUG	Sintilimab	200mg，iv，d1，q3w，a total of 3 cycles
DRUG	Lenvatinib	12 or 8mg/kg，po，qd，a total of 3 cycles

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-11-01
• Completion: 2025-11-01
• First posted: 2022-11-18
• Last updated: 2022-11-18

Locations

1 site across 1 country: China