NCT03906058

Brief Summary

The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma after failure of no less than second-line chemotherapy or targeted therapy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

April 5, 2019

Last Update Submit

October 22, 2023

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • disease control rate

    disease control rate

    30 months

Secondary Outcomes (4)

  • overall response rate

    30 months

  • progression-free survival

    30 months

  • overall survival

    30 months

  • duration of response

    30 months

Study Arms (1)

Anlotinib

EXPERIMENTAL
Drug: Anlotinib

Interventions

AnlotinibDRUG

All patients enrolled in the study will accept anlotinib treatment as a palliative treatment .

Anlotinib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • biopsy proved nasopharyngeal carcinoma;
  • stage IVB according to American Joint Committee on Cancer(AJCC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;
  • years or older; without other malignancy;
  • proper functioning of the major organs.

You may not qualify if:

  • allergic to anlotinib;
  • female within gestation period or lactation;
  • patients received drug of other clinical trial within 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Fang Y, Su N, Zou Q, Cao Y, Xia Y, Tang L, Tian X, Liu P, Cai Q. Anlotinib as a third-line or further treatment for recurrent or metastatic nasopharyngeal carcinoma: a single-arm, phase 2 clinical trial. BMC Med. 2023 Nov 7;21(1):423. doi: 10.1186/s12916-023-03140-x.

    PMID: 37936166DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 8, 2019

Study Start

April 29, 2019

Primary Completion

February 27, 2021

Study Completion

April 30, 2022

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

CN(1)