Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

Exclusion Criteria

• •A participant will be excluded from this study if any of the following criteria are met:
• •1. Participant has received previous systemic anticancer therapy.
• ••Participants receiving adjuvant or neoadjuvant treatment and completed ≥6 months prior to randomization are eligible.
• •2. Participant has mixed hepatocellular carcinoma - iCCA disease.
• •3. History and/or current evidence of any of the following disorders:
• •* Non-tumor related alteration of calcium-phosphorus homeostasis that is clinically significant in the opinion of the Investigator.
• •* Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator.
• •* Retinal disorder confirmed by retinal examination and considered clinically significant in the opinion of the ophthalmologist.
• •4. History or current evidence of uncontrolled ventricular arrhythmias
• •5. Fridericia's corrected QT interval (QTcF) \> 470 milliseconds (ms) on electrocardiogram (ECG) conducted during Screening.
• •6. Treatment with any of the following within the specified time frame prior to the first dose of study therapy, or failure to recover from side effects of these prior therapies:
• •* Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of study therapy).
• •* Radiotherapy (any dose) for extended field within 4 weeks or limited field radiotherapy within 2 weeks, and/or has not recovered from acute impact of radiotherapy.
• •* Participants with locoregional therapy, e.g. transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks.
• •* Any history of liver transplant.
• •7. A serious illness or medical condition(s) including, but not limited to, the following:
• •* Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for \<1 month).
• •* Known acute systemic infection.
• •* Myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within the previous 6 months.
• •* Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the Investigator.
• •* Congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death.
• •* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the participant inappropriate for entry into this study.
• •8. Participants with a history of another primary malignancy that is currently clinically significant, and has potential for metastases or currently requires active intervention.
• •9. Pregnant or breast-feeding female.
• •10. The participant is unable to take oral medication.