CClinicalTrials.gg
Status unknownNCT03591666Updated Jul 19, 2018

A Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas

A Phase 2 interventional study of Anlotinib in Head and Neck Carcinoma, Adenocarcinoma and Recurrent Disease, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Head and Neck Carcinoma
  • Adenocarcinoma
  • Recurrent Disease
  • Distantly Metastatic Malignant Neoplasm

Keywords

  • head and neck adenocarcinoma
  • Anlotinib
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 51 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 160 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    Study Group

    Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

    Drug: Anlotinib

Interventions

  • DrugAnlotinib

    Anlotinib p.o. qd

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: up to 24 months

Secondary outcomes

  1. Progress free survival (PFS)

    Time frame: up to 24 months

  2. Disease Control Rate (DCR)

    Time frame: up to 24 months

  3. Overall Survival (OS)

    Time frame: up to 24 months

07

Study locations

1 site
  • Shanghai ninth people's hospital
    Shanghai, Shanghai 200011, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03591666
Lead sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible party
Sponsor
First posted
Jul 19, 2018
Start date
Jul 15, 2018 (estimated)
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jul 19, 2018

Study contacts

Shengjin Dou
Contact
doushengjin@126.com
+8615800386875
Guopei Zhu
principal investigator · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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