Clinical trial NCT06446154: Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma
Official title: Fruquintinib in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors : A Single-arm, Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Immune Checkpoint Inhibitors
Anti-angiogenic Therapy
Second-line Treatment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou First People's Hospital
First posted: 2024-06-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Fruquintinib
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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%)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: ORR
timeFrame: Two years
Secondary outcomes:
measure: OS
timeFrame: Two years
measure: PFS
timeFrame: Two years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen university cancer center
state: Guangdong
Study officials:
References: