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

Phase 2

• Conditions: S-1 Plus Oxaliplatin
• Interventions: Drug: S-1,Oxaliplatin

• Registration Number: NCT04694404
• Lead Sponsor: Aiping Zhou

Brief 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.

Detailed Description

3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.

Study Timeline

• Study Start: 2016-05-11
• Study First Submitted: 2017-11-05
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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≥100×109/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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-1 Plus Oxaliplatin	S-1,Oxaliplatin	Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w)

Primary Outcome Measures

Name	Time	Method
PFS	6 months	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
ORR	6 months	Objective response rate
OS	1 year	Overall survival
The number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 year	Safety

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China