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The S-1 (AiYi) maintenance therapy with metastatic nasopharyngeal carcinoma received gemcitabine combined platinum chemotherapyrandomized controlled multicenter clinical study

The S-1 (AiYi) maintenance therapy with metastatic nasopharyngeal carcinoma received gemcitabine combined platinum chemotherapyrandomized controlled multicenter clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16007939
Enrollment
Unknown
Registered
2016-02-17
Start date
2016-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic nasopharyngeal carcinoma

Interventions

Experimental group:S1 maintenance therapy

Sponsors

The fourth affiliated hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18-65 years. 2) Histopathological diagnosis as nasopharyngeal squamous cell carcinoma; 3) Distant metastasis after comprehensive treatment; 4) Patients benefited from the gemcitabine combined cisplatin chemotherapy (CR+PR+SD) ; 5) KPS score>=70; 6) Expected lifetime> 6 months, with follow-up conditions; 7) Without serious heart and lung diseases; 8) Satisfy the following clinical laboratory standards: ANC>=1.5*10^9/L, PLT>=70*10^9/L, liver and kidney function being 1.5 times of the upper limit of normal value; 9) Have signed informed conset.

Exclusion criteria

Exclusion criteria: 1) Cognitive dysfunction; 2) Patients combined other malignant tumor; 3) Chemotherapy contraindications: serious bone marrow dysfunction, bleeding tendency,active infection, within 6 months after myocardial infarction, symptomatic heart disease (unstable angina,congestive heart failure or uncontrolled arrhythmias),immunosuppressive therapy, etc; 4) Women without using contraception during pregnancy and lactation,or fertility; 5) Drug abuse and alcohol addiction; 6) Patients having the allergic reaction for any drugs in the study; 7) Without follow-up conditions; 8) Inappropriate patients being considered by other researchers.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
overall survival;Disease remission rate;quality of life;

Countries

China

Contacts

Public ContactHuang Haixin
13507726193@163.com+86 13507726193

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026