1.Written informed consent to participate in the clinical trial is obtained voluntarily.
2.Patients aged 18 years or older on the date of consent.
3.Patients with a histopathologically confirmed diagnosis of advanced or recurrent salivary gland cancer.
4.Patients who are unresponsive or intolerant to standard therapy, or for whom no standard therapy is available. *
*Standard therapy includes trastuzumab for HER2-positive patients, bicalutamide + leuprorelin for androgen receptor-positive patients, and at least one regimen of cytotoxic chemotherapy (with or without platinum agents) for non-adenoid cystic carcinoma patients. No standard treatment is defined for adenoid cystic carcinoma patients, making them eligible even without prior treatment. Patients who experienced recurrence within 24 weeks (same weekday allowed) of the last dose after chemotherapy administered as a curative treatment (such as preoperative or postoperative chemoradiotherapy) are considered unresponsive to the drugs used.
5.Patients with at least one assessable lesion.
6.Patients with an Eastern Cooperative Oncology Group performance status PS of 0 or 1.
7.Patients expected to survive for at least 12 weeks.
8.Patients capable of oral administration.
9.Patients with adequate organ function as determined by the following clinical laboratory values measured within 14 days prior to registration (testing on the same weekday 14 days before registration is permitted). Additionally, no blood transfusion, G-CSF, or other hematopoietic factor products should be administered within 14 days prior to testing.
-Neutrophil count >=1,500/mm3
-Platelet count >= 100,000/mm3
-Hemoglobin >= 9.0 g/dL
-Serum creatinine =<1.5 mg/dL or creatinine clearance (CCr) value or measured value>=40mL/min
If CCr was measured by a 24-hour urine collection, either the measured or calculated value suffices.
Calculated value: Using the Cockcroft-Gault equation.
For men CCr = (140 - age) * body weight (kg) / 72 / serum creatinine(mg/dL)
For women CCr = 0.85 * (140-age) * body weight (kg) / 72 / serum creatinine (mg/dL)
-T-Bil =<1.5 * ULN (=<3.0 * ULN for Gilbert's syndrome)
-ALT and AST =<2.5 * ULN, or =<5 * ULN if liver metastasis is present (IU/L)
10.For patients with potential for pregnancy, a negative urine pregnancy test result within 14 days prior to registration (same weekday 14 days before registration is permitted). If the urine test is positive or inconclusive, a serum pregnancy test must be conducted to confirm a negative result. Patients agree to use contraception from the time of consent until at least 2 weeks after the final dose of the investigational drug.
1.Patients with symptomatic brain metastases. However, asymptomatic brain metastases not requiring corticosteroid initiation or dose increase within one week before enrollment, or brain metastases that have become asymptomatic post-radiation therapy, may be eligible.
2.Patients with leptomeningeal carcinomatosis.
3.Patients with clinically significant (requiring treatment) heart disease.
-History of myocardial infarction, unstable angina, or congestive heart failure (NYHA class III or IV) within 6 months prior to enrollment.
-Average QT interval corrected by Fridericia's formula (QTcF) exceeding 480 msec or factors increasing the risk of QT prolongation or arrhythmia (e.g., hypokalemia, congenital QT prolongation syndrome, family history of QT prolongation syndrome, or unexplained sudden death in a first-degree relative under 40).
-Left ventricular ejection fraction (LVEF) below 50% by echocardiography or multigated acquisition (MUGA).
4.Patients with >=2+ proteinuria by urine test strip or >=1.0 g/24h in urine protein quantification. Patients with >=1+ proteinuria by urine test strip must undergo a 24-hour urine collection test.
5.Patients with uncontrolled hypertension, defined as systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg despite optimal medical management.
6.History of gastroduodenal ulcer or ulcerative colitis within 6 months prior to enrollment, active bleeding from an unresected gastrointestinal tumor, perforation, fistula, or other gastrointestinal condition judged by the investigator to pose a risk of bleeding or perforation.
7.History of bleeding from other sites (e.g., hemoptysis or hematemesis) within 2 months prior to enrollment.
8.History of thromboembolic events, including deep vein thrombosis, pulmonary embolism, or arterial embolism, within 6 months prior to enrollment.
9.History of cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment.
10.Patients with malabsorption syndrome or other gastrointestinal disorders potentially affecting drug absorption.
11.Patients who have undergone surgery with general anesthesia within 4 weeks before enrollment. However, catheter procedures or minimally invasive surgeries (including biopsies; central venous catheter placement is allowed) may be eligible.
12.Patients who have received chemotherapy, hormonal therapy, or radiotherapy within 2 weeks before registration, or monoclonal antibodies (targeted therapy, antibody therapy, immunotherapy) within 4 weeks before registration.
13.Patients with synchronous malignancies at registration or metachronous malignancies within 2 years of disease-free status. However, patients with carcinoma in situ, superficial cancers (mucosal cancer), localized prostate cancer not requiring systemic therapy, or other solid tumors judged not to affect protocol treatment outcomes may be eligible based on the Trial Coordination Committee's decision.
14.Patients positive for HBs antigen or HCV antibodies.*
*Patients who are HCV antibody-positive but HCV-RNA negative are eligible.
15.Patients confirmed to be HIV positive (testing for HIV antibodies is not required for registration).
16.Patients with active, uncontrolled infections requiring intravenous antibiotic therapy.
17.Patients with tumor invasion into major vessels (e.g., pulmonary artery, superior or inferior vena cava).
18.Patients with other diseases, metabolic disorders, physical abnormalities, laboratory abnormalities, or other conditions (e.g., alcohol or drug abuse) that the investigator deems inappropriate for the investigational drug, likely to interfere with study interpretation, or likely to expose the participant to undue risk.
19.Patients with a history of hypersensitivity to the active ingredient of Fruquintinib or any other additives.
18age old over
No limit
Both
Salivary gland cancer
At the time of registration, patients will be randomly allocated to either the Fruquintinib + BSC group or the BSC group in a 2:1 ratio by the registration center. To prevent bias, minimization will be used with the following three stratification factors. The specific procedure for allocation will not be disclosed to researchers at participating institutions.
<Stratification Factors>
1.Histological Type (adenoid cystic carcinoma / non-adenoid cystic carcinoma)
2.PS(0/1)
3.Institution
-Investigator-assessed progression-free survival (PFS)
-Centrally and investigator-assessed objective response rate (ORR)
-Centrally and investigator-assessed disease control rate (DCR)
-Centrally and investigator-assessed duration of response (DOR)
-Centrally and investigator-assessed time to treatment failure (TTF)
-Overall survival (OS)
-Incidence of adverse events (assessed by Common Terminology Criteria for Adverse Events; CTCAE version 5.0)
- Quality of Life (QOL)
-Proportion of Decentralized Clinical Trials (DCT) introduction
