NCT07147101

Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment

A Prospective, Non-interventional Study of Different First-line Immunotherapy in Advanced Hepatocellular Carcinoma Patients: Efficacy and Immune Microenvironment Dynamics

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.

Detailed description

This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy, including anti-PD1+anti-VEGF, anti-PD1+TKI and anti-PD1+anti-CTLA4. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab will be administered by IV, 200 mg every 3 weeks
DRUG	Bevacizumab Biosimilar	Bevacizumab biosimilar will be administered by IV, 15 mg/kg every 3 weeks.
DRUG	Camrelizumab	Camrelizumab will be administered by IV, 200 mg every 2 weeks.
DRUG	Rivoceranib	Rivoceranib will be administered by oral 250 mg once daily.
DRUG	Nivolumab	Nivolumab will be administered by IV, 1 mg/kg every 3 weeks for up to four doses, followed by nivolumab 480 mg every 4 weeks
DRUG	Ipilimumab	Ipilimumab will be administered by IV, 3mg/kg every 3 weeks for up to four doses.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: China