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

Primary Purpose

Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib and TQB2450
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Zhongshan hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anlotinib+TQB2450

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 4, 2023
Last Updated
September 4, 2023
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06031480
Brief Title
Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anlotinib+TQB2450
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anlotinib and TQB2450
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate (ORR, RECIST v1.1)
Description
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yinghao Shen
Phone
0086-13916276098
Email
shen.yinghao@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huichuan Sun
Phone
0086-13701922065
Email
sun.huichuan@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Fan
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinghao Shen
Phone
+8613916276098
Email
shen.yinghao@zs-hospital.sh.cn

12. IPD Sharing Statement

Learn more about this trial

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

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