Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma

Sun Yat-sen University

Status and phase

Enrolling

Phase 2

Conditions

Immune Checkpoint Inhibitors

Anti-angiogenic Therapy

Hepatocellular Carcinoma

Second-line Treatment

Treatments

Drug: Fruquintinib

Study type

Interventional

Funder types

Other

Identifiers

NCT06446154

FRU-001

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.