Clinical trial · Interventional
Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer
The Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced or Recurrent Gastric Cancer
NCT04694404CI-TRIAL-00049258unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| S-1 Plus Oxaliplatin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1,Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1 Plus Oxaliplatin
- description
- 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)
- interventionNames
- Drug: S-1,Oxaliplatin
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 6 months
- description
- Progression-free survival
Secondary outcomes (3)
- measure
- ORR
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJiang Z, Zhou A, Sun Y, Zhang W. Biweekly oxaliplatin plus S1 for Chinese elderly patients with advanced gastric or gastroesophageal junction cancer as the first-line therapy: a single-arm, phase 2 study. BMC Cancer. 2022 Mar 9;22(1):253. doi: 10.1186/s12885-022-09332-7. PMID 35264150