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

Hepatocellular Carcinoma Clinical Trial

— FAITH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06031480
• Other study ID #: KY2023297
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 31, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Shanghai Zhongshan Hospital
• Contact: Yinghao Shen
• Phone: 0086-13916276098
• Email: shen.yinghao[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Anlotinib and TQB2450
Anlotinib: 10mg PO, QD, D1-14, Q3W; TQB2450: 1200 mg, IV, D1, Q3W. Anlotinib and TQB2450 will be administered until the disease progression, intolerable toxicity, death, withdrawal of consent.

Locations

Country	Name	City	State
China	Zhongshan hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR, RECIST v1.1)	ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs	24 months