Clinical trial · Interventional
A Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
A Non-randomized Phase II Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
NCT03591666CI-TRIAL-00033855unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a non-randomized, phase II, open label study of anlotinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck. The primary purpose of this study is to evaluate the efficacy of anlotinib.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Distantly Metastatic Malignant Neoplasm | — | UNRESOLVED | — |
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Group
- description
- Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- interventionNames
- Drug: Anlotinib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 24 months
Secondary outcomes (3)
- measure
- Progress free survival (PFS)
- timeFrame
- up to 24 months
- measure
- Disease Control Rate (DCR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed head and neck adenocarcinoma. 2. Patients with recurrent or metastatic head and neck adenocarcinoma who are not candidates for curative surgery or radiotherapy. 3. Measurable disease per the RECIST criteria. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. Provision of written informed consent. 6. Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for 3 months after completion of trial therapy. Exclusion Criteria: 1. Prior treatment with Anlotinib 2. With pleural effusion or ascites, cause respiratory syndrome 3. Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients 4. Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, 5.Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping 6.Symptoms of brain metastases cannot be controlled and treated within less than 2 months 7.severe and failed to controlled diseases 8.Occurred venous thromboembolic events within 6 months
References
Publications (0)
Data not yet available
No reference posted for this study.