Single-center, single-arm phase II clinical trial of Anlotinib for the treatment of recurrent inoperable or distant metastases of salivary gland carcinoma of head and neck

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100047475

Enrollment

Unknown

Registered

2021-06-20

Start date

2020-05-18

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Salivary gland carcinoma

Interventions

Experimental group:Anlotinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with recurrence is more than 6 months after the end of the first treatment, or patients with distant metastasis (including initial diagnosis or recurrence ) are found. 2. Salivary carcinoma is confirmed by histologically /or cytologically. 3. At least one measurable lesion must be examined by CT or MRI (RECIST 1.1 criteria); with clinical stages: rT3-4N0-1M0, rT0-4N2-3M0, rT0-4N0-3M1, rIII-IV, T1-4N0-3M1 (NCCN 2018 edition). 4. Aged 18 to 70 years. 5. The patients must be informed of the investigational nature of this study and givewritten informed consent. 6. According to the ECOG criteria :score is 0 or 1.

Exclusion criteria

Exclusion criteria: 1. Patients with major vascular invasion or patients with necrotic lesions, or patients with massive hemorrhage that may occur during the follow-up study as determined by the researchers. 2. Patients with other malignant tumors. 3. Patients with any severe and/or uncontrolled disease, long-term untreated wounds or fractures. 4. Hematological lesions with past or present bleeding and potential bleeding risk. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues (e.g., active gastrointestinal ulcers). 5. Patients who have experienced thrombosis (AVT), such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (DVT) and pulmonary embolism before the first medication. 6. Received any anti-infection vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment. 7. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
disease control rate, DCR;	—

Secondary

Measure	Time frame
Local replase-free survival ;Progression Free Survival, PFS;Quality of life;overall survival;	—

Countries

China

Contacts

Public ContactAnkui Yang

Department of Head and Neck Surgery, Sun Yat-Sen University Cancer Center

yangak@sysucc.org.cn+86 13903052829

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026