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Completed

NCT Number: NCT03906058

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

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

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anlotinib

Drug

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

Primary outcomes

  1. disease control rate

    Time frame: 30 months

    disease control rate

Secondary outcomes

  1. overall response rate

    Time frame: 30 months

    overall response rate

  2. progression-free survival

    Time frame: 30 months

    progression-free survival

  3. overall survival

    Time frame: 30 months

    overall survival

  4. duration of response

    Time frame: 30 months

    duration of response

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 8, 2019
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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