- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01650766
Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
TS, DPD and OPRT are the key enzymes on the metabolic pathway of 5-Fu. We will retrospectively analyze the clinicopathological features of the patients who have suffered an inoperative or recurrent gastric cancers and administrated with S-1, such as the overall survival (OS), progressive-free survival (PFS), Lauren's classification and toxicity of S1, etc. We will divide the patients into several subgroups according to the parameters above, and then investigate the correlation between the parameters and the expression of TS, DPD and OPRT.
All of the analysis is retrospective, there is no different treatment operation once the subject enrolled in this study.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Beijing
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Beijing, Beijing, Kina, 100071
- Rekrytering
- 307 Hospital of PLA
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Kontakt:
- Xu Jianming, M.D.
- Telefonnummer: +861051168358
- E-post: jmxu2003@yahoo.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Histologically confirmed, inoperable or advanced gastric cancer patients who received at most 1st line treatment
- Aged 18 years or older
- KPS performance status of ≥ 70.
- Anticipated life expectancy of ≥ 3 months.
Adequate organ function, including bone marrow, kidney and liver.
- ANC ≥ 1.5×109/L and hemoglobin ≥ 8g/dL and platelet count ≥ 100×109/L
- Serum total bilirubin ≤ 1.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)
- Serum creatinine ≤ 1.5 x ULN and CLcr > 60 ml/min
- Written informed consent can be obtained prior to their participation in the trial.
Exclusion Criteria:
- History of severe drug allergy , or an allergy to any components of S1
- Subjects who have received chemotherapy, immunotherapy or radiotherapy within two weeks
- Alimentary tract hemorrhage, diarrhea or aphagosis at the present stage
- Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric disorders.
- Subjects who are regarded to be unsuitable for this trial by the investigator.
- Subjects who are participating in other clinical trials
- Subjects with ascites draining or severe infection
- Pregnant or breast-feeding women
Studieplan
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Utredare
- Huvudutredare: Xu Jianming, M.D., The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AGC-307PLAH-XJM
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