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Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers

18 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers

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.

Inclusion Criteria:

1. Histologically confirmed, inoperable or advanced gastric cancer patients who received
at most 1st line treatment

2. Aged 18 years or older

3. KPS performance status of ≥ 70.

4. Anticipated life expectancy of ≥ 3 months.

5. 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

6. Written informed consent can be obtained prior to their participation in the trial.

Exclusion Criteria:

1. History of severe drug allergy , or an allergy to any components of S1

2. Subjects who have received chemotherapy, immunotherapy or radiotherapy within two

3. Alimentary tract hemorrhage, diarrhea or aphagosis at the present stage

4. Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric

5. Subjects who are regarded to be unsuitable for this trial by the investigator.

6. Subjects who are participating in other clinical trials

7. Subjects with ascites draining or severe infection

8. Pregnant or breast-feeding women

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Xu Jianming, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences


China: Ethics Committee

Study ID:




Start Date:

February 2012

Completion Date:

October 2012

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms