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Recruiting NCT06446154

Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma

Phase II Interventional Hepatocellular Carcinoma Immune Checkpoint Inhibitors Anti-angiogenic Therapy Second-line Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fruquintinib.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Immune Checkpoint Inhibitors, Anti-angiogenic Therapy, Second-line Treatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Fruquintinib in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors : A Single-arm, Phase II Study

Overview

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

  • Drug Fruquintinib
    Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.

Primary outcome measures

  • ORR [Time frame: Two years]
Secondary outcome measures (2)
  • OS [Time frame: Two years]
  • PFS [Time frame: Two years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen university cancer center — Guangzhou

Identifiers

NCT: NCT06446154 · FRU-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗