Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy

NCT ID: NCT03906058

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2022-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anlotinib

Group Type EXPERIMENTAL

Anlotinib

Intervention Type DRUG

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

Interventions

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Anlotinib

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Qingqing Cai

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37936166 (View on PubMed)

Other Identifiers

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B2018-167

Identifier Type: -

Identifier Source: org_study_id

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