Hepatocellular CarcinomaPhase 2FAITHNCT06031480
Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors
A Phase 2 study testing Anlotinib and TQB2450 in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Anlotinib and TQB2450
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- ECOG performance status 0 or 1
- Adequate organ function
- Life expectancy of at least 3 months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Zhongshan hospital
Shanghai, Shanghai Municipality, 200032
Yinghao Shen, +8613916276098, shen.yinghao@zs-hospital.sh.cn
About this study
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
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Anlotinib and TQB2450
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib and TQB2450Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| anlotinib+TQB2450 | Experimental | Not described Receives: Drug: Anlotinib and TQB2450 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start31 Oct 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jia Fan, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031480
- Sponsor's protocol ID
- KY2023297
- Acronym
- FAITH
- Status last verified
- Jul 2023
- First submitted
- 4 Sep 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06031480
- Acronym / sponsor ID
- FAITH / KY2023297
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 31 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anlotinib+TQB2450 | Experimental | Drug: Anlotinib and TQB2450 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib and TQB2450Anlotinib: 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. | Drug | anlotinib+TQB2450 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Fan principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib and TQB2450 in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yinghao Shen (0086-13916276098, shen.yinghao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR, RECIST v1.1) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.