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NCT Number: NCT06446154

Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen university cancer center

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Ming Shi

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FRUQUINTINIB

Drug

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

Primary outcomes

  1. ORR

    Time frame: Two years

    Objective response rate

Secondary outcomes

  1. OS

    Time frame: Two years

    Median overall survival

  2. PFS

    Time frame: Two years

    Median progression-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Shi

CONTACT

[email protected]

020-87343115

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Guangzhou First People's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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