Hepatocellular CarcinomaPhase 2NCT06446154
Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Fruquintinib in people with Hepatocellular Carcinoma and Immune Checkpoint Inhibitors, run by Sun Yat-sen University at 1 site in China.
Trial summary
Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Immune Checkpoint Inhibitors, Anti-angiogenic Therapy
- What is being tested?
- Fruquintinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2024to 1 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 years or older
- with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria
- who had previously received immune checkpoint inhibitors
- had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria
- had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- had a Child-Pugh liver function score of 7 or less
- had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin < 30μmol/l, albumin ≥ 30g/l, aspartate transaminase and alanine transaminase ≤ 5×upper limit of the normal, creatinine clearance rate of ≤ 1.5×upper limit of the normal, and left ventricular ejection ≥ 45%)
Who cannot join
- history of HIV, organ allograft
- combined with other malignant tumors
- evidence of hepatic decompensation, bleeding diathesis or event
- allergy to the investigational agents or any agent given in association with this trial
- incomplete medical information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen university cancer center
Guangzhou, Guangdong
Ming Shi
About this study
Official title: Fruquintinib in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors : A Single-arm, Phase II Study
Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC.
As a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor -1/2/3 (VEGFR 1/2/3), fruquintinib had demonstrated a strong antitumor efficacy in colorectal cancer patients who had previously received standard chemotherapy. Compared with placebo, fuquinitinib significantly extended overall survival in patients with metastatic colorectal cancer (median OS, 9.3 months vs 6.6 months; HR, 0.65; p<0.001) and progression-free survival (median PFS, 3.7 months vs 1.8 months; HR, 0.26; p<0.001). Additionally, a phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment, with a median PFS of 7.4 months and a tumor response rate of 31.6%.
Therefore, we intend to conduct this clinical study to explore the efficacy and safety of fruquintinib as second-line treatment for patients with unresectable HCC previously treated with immune checkpoint inhibitors.
- Conditions
- Hepatocellular Carcinoma, Immune Checkpoint Inhibitors, Anti-angiogenic Therapy, Second-line Treatment
- Being tested
- Fruquintinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib | Experimental | Fruquintinib monotherapy Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: Two years
Secondary outcomes (2)
OS
Median overall survival
Measured: Two years
PFS
Median progression-free survival
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start27 Dec 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jul 2026 (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 Sun Yat-sen UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Fruquintinib
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou First People's Hospital
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446154
- Sponsor's protocol ID
- FRU-001
- Status last verified
- Dec 2024
- First submitted
- 30 May 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors : A Single-arm, Phase II Study
- ClinicalTrials.gov ID
- NCT06446154
- Acronym / sponsor ID
- FRU-001
- Conditions
- Hepatocellular Carcinoma, Immune Checkpoint Inhibitors, Anti-angiogenic Therapy, Second-line Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou First People's Hospital
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 6 Jun 2024 (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.
Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC.
As a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor -1/2/3 (VEGFR 1/2/3), fruquintinib had demonstrated a strong antitumor efficacy in colorectal cancer patients who had previously received standard chemotherapy. Compared with placebo, fuquinitinib significantly extended overall survival in patients with metastatic colorectal cancer (median OS, 9.3 months vs 6.6 months; HR, 0.65; p<0.001) and progression-free survival (median PFS, 3.7 months vs 1.8 months; HR, 0.26; p<0.001). Additionally, a phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment, with a median PFS of 7.4 months and a tumor response rate of 31.6%.
Therefore, we intend to conduct this clinical study to explore the efficacy and safety of fruquintinib as second-line treatment for patients with unresectable HCC previously treated with immune checkpoint inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fruquintinib
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib | Experimental | Drug: FruquintinibFruquintinib monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients aged 18 years or older
- with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria
- who had previously received immune checkpoint inhibitors
- had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria
- had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (5 listed)
- history of HIV, organ allograft
- combined with other malignant tumors
- evidence of hepatic decompensation, bleeding diathesis or event
- allergy to the investigational agents or any agent given in association with this trial
- incomplete medical information.
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 |
|---|---|---|
| FruquintinibFruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week. | Drug | Fruquintinib |
Primary outcome
ORR
Time frame: Two years
Objective response rate
2 secondary outcomes
OS
Time frame: Two years
PFS
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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.
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 Fruquintinib in people with Hepatocellular Carcinoma and Immune Checkpoint Inhibitors, run by Sun Yat-sen University 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Shi (020-87343115, shiming@sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Two years). 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 31 Dec 2024.