Study of Combination Treatment Using Anlotinib and TQB2450 in Patients With Advanced Hepatocellular Carcinoma Who Failed Prior Immune Checkpoint Inhibitor Therapies: a Single Arm, Multicenter Clinical Trial

Shanghai Zhongshan Hospital1 site in 1 country55 target enrollmentOctober 31, 2023

ConditionsHepatocellular Carcinoma

InterventionsAnlotinib and TQB2450

DrugsAnlotinib and TQB2450

Overview

Phase: Phase 2
Intervention: Anlotinib and TQB2450
Conditions: Hepatocellular Carcinoma
Sponsor: Shanghai Zhongshan Hospital
Enrollment: 55
Locations: 1
Primary Endpoint: Objective response rate (ORR, RECIST v1.1)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an multi-center, single arm, exploratory study to evaluate the efficacy and safety of anlitinib combined with TQB2450 in patients with advanced hepatocellular carcinoma （HCC）who failed prior immune checkpoint inhibitor therapies.

Registry

clinicaltrials.gov

Start Date

October 31, 2023

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Zhongshan Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The participants must be required to sign an informed consent
•Hepatocellular carcinoma patients confirmed by pathological or cytological examination, or who meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of primary hepatocellular carcinoma" (2022)
•At least one measurable lesion (RECIST 1.1)
•Chinese Liver Cancer Staging (CNLC): CNLC-IIa, IIb, IIIa, IIIb (BCLC-B and C) that are not suitable for local treatment (TACE, HAIC, etc.) or that have progressed after local treatment
•The previous treatment plan for patients before enrollment was a standard treatment plan containing immune checkpoint inhibitors, and patients with progression or intolerance were evaluated based on the RECIST v1.1 standard
•Child-Pugh Score, Class A or better B
•ECOG performance status 0 or 1
•Adequate organ function
•Life expectancy of at least 3 months

Exclusion Criteria

•Patients who have received local treatment (including TACE, ablation, HAIC, radiotherapy) and are less than 1 month after enrollment
•Patients who have received ≥ 2 treatments with immune checkpoint inhibitor regimens
•Adverse events above level 1(NCI-CTCAE v5.0) caused by any previous treatment that have not returned to ≤ level 1 (excluding hair loss); Patients with previous severe immune-related AEs requiring permanent cessation of immunotherapy
•Pregnant or lactating wome