Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aiping Zhou
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma;

• Aged≥60

• ability of oral administration;

• CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1);

• Untreated

• more than 12 months after the last adjuvant/neoadjuvant chemotherapy;

• ECOG=0-2;

• Available organ function: ALT≤2.5xULN;AST≤2.5xULN;If patients have hepaticmetastasis,ALT≤2.5xULN,AST≤2.5xULN;ALP≤2xULN;TBIL≤1.0xULN;NEUT≥1.5×109/L;PLT≥10 0×109/L;Hb≥90g/L;Creatinine≤1.0xULN;Creatinine Clearance≥60ml/min

• Informed consent;

• Expected survival more than 3 months;More than 3 weeks after major surgery.

Exclusion Criteria:

• Neoadjuvant and/or adjuvant have been treated with more than two plans;

• In the past two years, the total dose of oxaliplatin≥800mg/m2;

• Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer;

• Symptomatic brain metastases or soft meningeal metastasis;

• Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure;

• Serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); Chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);Gastrointestinal bleeding requires regular blood transfusion;HIV or AIDS; Mental illness; Neuropathy grade≥2;Infectious diseases or inflammation, temperature≥38℃;

• Known allergy to drugs in the study;

• Pregnant or lactating women;

• Both male and female subjects of potential fertility have to agree effective birth control during the entire study;

• Experimental drugs used no more than 4 weeks;

• Other conditions the researchers considered ineligible for the study.