The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06031480
Recruitment Status : Not yet recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Collaborator:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 31, 2023
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Objective response rate (ORR, RECIST v1.1) [ Time Frame: 24 months ]
    ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031480


Contacts
Layout table for location contacts
Contact: Yinghao Shen 0086-13916276098 shen.yinghao@zs-hospital.sh.cn
Contact: Huichuan Sun 0086-13701922065 sun.huichuan@zs-hospital.sh.cn

Locations
Layout table for location information
China, Shanghai
Zhongshan hospital
Shanghai, Shanghai, China, 200032
Contact: Yinghao Shen    +8613916276098    shen.yinghao@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Jia Fan Shanghai Zhongshan Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT06031480    
Other Study ID Numbers: KY2023297
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: July 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases