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

NCT03400592 | Unknown Phase 2 DMC

• 1 other identifier: NIEGA
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms

Keywords

gastric adenocarcinoma; EGFR; Irinotecan; Nimotuzumab; biomarker

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  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

  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

Secondary Outcomes (5)

• Overall survival

  3 years after first enrollment

• Progression free survival

  3 years after first enrollment

• Disease control rate

  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

• Safety

  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

• Potential predictive biomarkers of nimotuzumab

  3 years after first enrollment

Study Arms (1)

irinotecan and nimotuzumab

EXPERIMENTAL

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

Drug: Irinotecan; Drug: nimotuzumab

Interventions

Irinotecan DRUG

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

irinotecan and nimotuzumab

nimotuzumab DRUG

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

irinotecan and nimotuzumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Peking cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan; nimotuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of GI oncology, Beijing Cancer Hospital

Study Record Dates

• First Submitted: October 10, 2015
• First Posted: January 17, 2018
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

CN (1)