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

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Anlotinib and TQB2450

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06031480

KY2023297

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

anlotinib+TQB2450

Experimental group

Treatment:

Drug: Anlotinib and TQB2450