Clinical trial · Interventional
A Efficacy and Tolerability Study of TEGAFOX Sequential S-1 in the Treatment of Adjuvant Chemotherapy for Gastric Cancer
A Efficacy and Tolerability Study of Uracil/Ftorafur/Leucovorin Combined With Oxaliplatin (TEGAFOX) Sequential S-1 or SOX Sequential S-1 and S-1 Monotherapy in the Treatment of Adjuvant Chemotherapy for Gastric Cancer
- 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 is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SOX | Drug | — | UNRESOLVED |
| SOX Sequential S-1 | Drug | — | UNRESOLVED |
| TEGAFOX Sequential S-1. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- SOX Sequential S-1 Group
- description
- Patients received chemotherapy with" oxaliplatin+ S-1 " for 6 months and sequential "S-1" for 6 months
- interventionNames
- Drug: SOX Sequential S-1
- type
- ACTIVE_COMPARATOR
- label
- SOX Group
- description
- Patients received chemotherapy with" oxaliplatin+ S-1 " for 12 months
- interventionNames
- Drug: SOX
- type
- EXPERIMENTAL
- label
- TEGAFOX Sequential S-1
- description
- Patients received chemotherapy with" TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium) " for 6 months and sequential "S-1" for 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 75≧Age≧18 * Histologically or cytologically confirmed gastrointestinal cancer * Stage Ⅱ or Ⅲ or Ⅳ * ECOG ≦2 * Accept the gastric cancer radical resection * Life expectancy of at least three months * Written informed consent to participate in the trial Exclusion Criteria: * History of severe hypersensitivity reactions to the ingredients of S-1\\TF\\5-FU/calcium folinate or oxaliplatin * Inadequate hematopoietic function which is defined as below: * white blood cell (WBC) less than 5x10\^9/L * absolute neutrophil count (ANC) less than 2x10\^9/L * platelets less than 100\*10\^9/L * Inadequate hepatic or renal function which is defined as below: * serum bilirubin greater than 2 times the upper limit of normal range * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases * blood creatinine level greater than 2 times ULN * Presence of peripheral neuropathy * Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug * Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male) * Psychiatric disorder or symptom that makes participation of the patient difficult; * Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months * Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
References
Publications (0)
Data not yet available