Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors

Phase 2

Not yet recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Anlotinib and TQB2450

• Registration Number: NCT06031480
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Last Update Submitted: 2023-09-04
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Study Start: 2023-10-31
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anlotinib+TQB2450	Anlotinib and TQB2450	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR, RECIST v1.1)	24 months	ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs

Trial Locations

Locations (1)

Zhongshan hospital; 🇨🇳 Shanghai, Shanghai, China