Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma

NCT ID: NCT03400592

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

irinotecan and nimotuzumab

Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

nimotuzumab

Intervention Type: DRUG

400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

Interventions

Irinotecan

180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

Intervention Type: DRUG

nimotuzumab

400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Head of Department of GI oncology, Beijing Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking cancer hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

lin shen, MD. PhD

Role: primary

linshenpku@163.com

(86)10-88196561

jifang gong, MD. PhD

Role: backup

gongjifang@gmail.com

(86)10-88196561

Other Identifiers

NIEGA

Identifier Type: -

Identifier Source: org_study_id