这是一项开放标签、多国、随机的2期研究，确认20 mg futibatinib的临床益处，并评估16 mg futibatinib在先前治疗的CCA中含有FGFR2基因融合和其他重排的安全性和有效性。
适应症：Advanced Cholangiocarcinoma、FGFR2 Fusions、Gene Rearrangement
入组条件
纳入标准
- Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
- Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement
- Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
- Documentation of radiographic disease progression on the most recent prior therapy
- Measurable disease
- performance status 0 or 1
- Adequate organ function
排除标准
- History or current evidence of calcium and phosphate homeostasis disorder
- Current evidence of clinically significant retinal disorder
- Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:
- Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
- Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
- Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer
- Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.
- Patients with prior FGFR-directed therapy
- A serious illness or medical condition(s) including (but not limited to) the following:
- Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month
- Known acute systemic infection
- Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV New York Heart Association \[NYHA\] Classification) within the previous 2 months; if \>2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms
- Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study.
- Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.
- Pregnant or lactating female.
- Known hypersensitivity or severe reaction to futibatinib or its excipients.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。