Clinical trial · Interventional
Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma
Multi-center Phase II Trial of Nimotuzumab Plus Irinotecan in Patients With High EGFR Expression After Failure of First-line Treatment in Recurrent or Metastatic Gastric Adenocarcinoma（NIEGA）
NCT03400592CI-TRIAL-00031204NIEGAunknownPhase 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)
The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in 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 Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irinotecan and nimotuzumab
- description
- Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
- interventionNames
- Drug: Irinotecan
- Drug: nimotuzumab
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
- description
- CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1.Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response
Secondary outcomes (5)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria: * Willing to sign ICF * Above 18 years * KPS score≥70 * Expected survival time more than 90 days * Subjects with EGFR overexpression (2+ or 3+ in IHC) * With target lesions in spiral CT or MRI examination within 30 days * 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 ,platinum agent and Paclitaxel agent. * Lab test of baseline meet following criteria * Hemoglobin higher than 9.0g/dL * Neutrophil higher than 1,500/mm3 * PLT higher than 10.0 104/mm3 * Bilirubin lower than 1.5 times of upper limit of normal range * AST,ALT,ALP lower than 2.5 times of upper limit of normal range * Creatinine lower than upper limit of normal range * When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range Exclusion Criteria: * Patients who have received irinotecan * Patients who are allergic to irinotecan or nimotuzumab. * Other active malignancy within the last 5 years * Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures * Investigator judge not eligible to this trial
References
Publications (0)
Data not yet available
No reference posted for this study.