Clinical trial · Interventional
Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer
A Randomized, Open-label, Japan-Korea-Taiwan Collaborative Phase 3 Study to Compare the Efficacy of Nimotuzumab and Irinotecan Combination Therapy Versus Irinotecan Monotherapy as Second Line Treatment in Subjects With Advanced or Recurrent Gastric and Gastroesophageal Junction Cancer
NCT01813253CI-TRIAL-00032224terminatedPhase 3ClinicalTrials.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 evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.
Conditions
Conditions (2)
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 |
| Gastroesophageal Junction Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Irinotecan and nimotuzumab
- description
- Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
- interventionNames
- Drug: Irinotecan
- Drug: Nimotuzumab
- type
- ACTIVE_COMPARATOR
- label
- Irinotecan
- description
- Administration of irinotecan 150 mg/m2 IV once every 2 weeks
- interventionNames
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Around 4.5 years after first subject randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma. 2. Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent. 3. Subjects with EGFR overexpression (2+ or 3+ in IHC) Exclusion Criteria: 1. Subjects who have received irinotecan 2. Subjects who have received EGFR-directed therapy 3. Other active malignancy within the last 5 years
References
Publications (0)
Data not yet available
No reference posted for this study.