Clinical trial · Interventional
Study of Oxaliplatin, Irinotecan, and S-1 in Gastric Cancer
Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Gastric Cancer
NCT02527785CI-TRIAL-00029218completedPhase 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)
This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced 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 |
|---|---|---|---|
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin, Irinotecan, S-1(OIS) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oxaliplatin, Irinotecan, S-1(OIS)
- description
- triple combination with oxaliplatin, irinotecan, and S-1. Treatment will be delivered as a 2-week cycle. 1. Oxaliplatin 65 mg/m2 iv on day 1 2. Irinotecan 135 mg/m2 iv on day 1 3. S-1 80 mg/m2/day on day 1-7
- interventionNames
- Drug: Oxaliplatin, Irinotecan, S-1(OIS)
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 1.5 years
- description
- Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1
Secondary outcomes (3)
- measure
- progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of stomach (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * More than 3 months expected life span * Measurable lesion by RECIST criteria version 1.1 * Palliative chemotherapy naive * Adequate organ functions * Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital Exclusion Criteria: * Positive Her2 status on participants' cancer tissue. * Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer. * Participants who had received radiation therapy for target lesions 4 weeks before study enrollment * Participants who had received major surgery 4 weeks before study enrollment * Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding * Participants with central nervous system(CNS) metastases * Participants with peripheral sensory neuropathies with impaired functional activities * Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.
References
Publications (1)
- DERIVEDKim HS, Ryu MH, Zang DY, Park SR, Han B, Kang WK, Rha SY, Jung M, Kim JS, Kang BW, Lee KH, Rho SY, Kim JH, Kim KC, Cho JW, Choi DR, Lim H, Kang HS, Soh JS, Kim MJ, Seo J, Kang YK. Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer: the Korean Cancer Study Group ST14-11. Gastric Cancer. 2018 Sep;21(5):802-810. doi: 10.1007/s10120-018-0794-1. Epub 2018 Jan 25. PMID 29372461