Anti-angiogenic Therapy, Hepatocellular Carcinoma, Immune Checkpoint Inhibitors, Second-line Treatment
Conditions
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.
Interventions
DRUGFruquintinib
Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.
Sponsors
Guangzhou First People's Hospital
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Fruquintinib
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Two years | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | Two years | Median overall survival |
| PFS | Two years | Median progression-free survival |
Countries
China
Contacts
Primary ContactMing Shi
Outcome results
None listed