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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06031480

Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Anlotinib and TQB2450	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 31, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anlotinib+TQB2450	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.

Arm

Intervention/Treatment

Experimental: anlotinib+TQB2450

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan hospital	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jia Fan, Shanghai Zhongshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT06031480

Other Study ID Numbers:

KY2023297

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Sep 11, 2023