The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation

Affiliated Hospital of Qinghai University

Status: Completed

Conditions: Gastric Cancer

Treatments: Other: Microsatellite instability

Study type: Observational

Funder types: Other

Identifiers

NCT03485196

AHQU-2017003

Details and patient eligibility

About

The relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.

Full description

To explore the relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histopathology or cytopathology proven gastric cancer;

2. Operable advanced gastric cancer patients: primary lesions can be completely excision, no distant metastasis;

3. Postoperative patients who can tolerate 5-FU based (5-FU，S-1 or Capecitabine) adjuvant chemotherapy;

4. Life expectancy of at least 6 months;

5. ECOG（Eastern Cooperative Oncology Group ） score 0-1;

6. Age: 18~80 years old;

7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).

   • For example: WBC（White blood cell count ）>4.0×109/L; NEU（Neutrophils）>1.5×109/L; PLT（Platelet）>100×109/L;

8. Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;

9. Not concomitant with other uncontrollable benign diseases before the recruitment;

10. Voluntarily signed the informed consent.

Exclusion criteria

1. Advanced gastric cancer patients with distant metastasis and inoperable ;
2. Patients who cannot tolerate 5-FU based adjuvant chemotherapy;
3. Pregnant or lactating women;
4. Patients who have no desire to participate in the study.

Trial design

1,000 participants in 3 patient groups

MSI-H group

Description:

We use the immunohistochemical expression of mismatch repair proteins (MutS protein homolog 2( MSH2),MutS protein homolog 6( MSH6) and PMS2（postmeiotic segregation increased 2 ）) to Determine the MSI status . When one antibodies or more show negative nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite instability high (MSI-H).

Treatment:

Other: Microsatellite instability

MSI-L group

Description:

We use the immunohistochemical expression of mismatch repair proteins (MLH1, MSH2, MSH6 and PMS2) to Determine the MSI status . when all the four antibodies show positive nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite stable (MSI-L).

Treatment:

Other: Microsatellite instability

MSS group

Description:

We use the immunohistochemical expression of mismatch repair proteins (MLH1, MSH2, MSH6 and PMS2) to Determine the MSI status . when all the four antibodies show positive nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite stable (MSS).

Treatment:

Other: Microsatellite instability