- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02789189
Nedaplatin Combined With Gemcitabine in the Treatment of Recurrent and/or Metastatic Nasopharyngeal Carcinoma : a Single Arm and Phase Ⅱ Clinical Trail
September 4, 2019 updated by: Qingqing Cai, Sun Yat-sen University
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of nedaplatin combined with gemcitabine in the treatment of recurrent and metastatic nasopharyngeal carcinoma
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- biopsy proved nasopharyngeal carcinoma; stage IVc according to Union for International Cancer Control (UICC) edition VII,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 nedaplatin and/or gemcitabine; female within gestation period or lactation; patients received drug of other clinical trail within 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: nedaplatin combined with gemcitabine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
September 4, 2019
Study Registration Dates
First Submitted
May 29, 2016
First Submitted That Met QC Criteria
May 29, 2016
First Posted (Estimate)
June 2, 2016
Study Record Updates
Last Update Posted (Actual)
September 6, 2019
Last Update Submitted That Met QC Criteria
September 4, 2019
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Nedaplatin
Other Study ID Numbers
- B2015-073-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent and Metastatic Nasopharyngeal Carcinoma
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National Cancer Institute (NCI)NRG OncologyTerminatedRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Metastatic Nasopharyngeal Nonkeratinizing Carcinoma | Metastatic Nasopharyngeal Undifferentiated Carcinoma | Nasopharyngeal... and other conditionsUnited States, Canada, China, Singapore
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Jiangsu HengRui Medicine Co., Ltd.Sun Yat-sen UniversityCompletedRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal CarcinomaChina
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National University Hospital, SingaporeRecruitingRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal CarcinomaSingapore
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National Cancer Institute (NCI)RecruitingRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal CarcinomaUnited States, China
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Sun Yat-sen UniversityActive, not recruitingNasopharyngeal Carcinoma | Chemotherapy Effect | Immunotherapy | Recurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal CarcinomaChina
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Alliance for Clinical Trials in OncologyNot yet recruitingRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma
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Sun Yat-sen UniversityActive, not recruitingNasopharyngeal Carcinoma | Chemotherapy Effect | Immunotherapy | Recurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Carcinoma | Molecular Targeted TherapyChina
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Cancer Institute and Hospital, Chinese Academy...RecruitingRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal CarcinomaChina
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Alain AlgaziAstraZeneca; Incyte CorporationWithdrawnRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma | Epstein-Barr Virus Positive | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma
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BeiGeneActive, not recruitingRecurrent or Metastatic Nasopharyngeal CancerChina, Taiwan, Thailand
Clinical Trials on nedaplatin and gemcitabine
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Third Military Medical UniversityUnknown
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The First Affiliated Hospital with Nanjing Medical...Not yet recruitingEsophageal Squamous Cell Carcinoma
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Guangxi Medical UniversityLiuzhou Workers Hospital; Wuzhou Red Cross Hospital; Guilin Medical College; People... and other collaboratorsUnknownNasopharyngeal CarcinomaChina
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Sun Yat-sen UniversityPeking University; Zhejiang Cancer Hospital; Xiangya Hospital of Central South... and other collaboratorsNot yet recruitingNasopharyngeal CarcinomaChina
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He XiaUnknown
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The First Affiliated Hospital of Zhengzhou UniversityNot yet recruitingLocally Advanced Esophageal Squamous Cell CarcinomaChina
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Sun Yat-sen UniversityThe First Affiliated Hospital of Guangdong Pharmaceutical University; Guangzhou... and other collaboratorsCompletedNasopharyngeal CarcinomaChina