NCT03400592

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）

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	Irinotecan	180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
DRUG	nimotuzumab	400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2018-01-17
• Last updated: 2018-01-17

Locations

1 site across 1 country: China