EGFR-targeted Therapy for Gastric Cancer

NCT ID: NCT04077255

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2023-12-31

Brief Summary

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Based on targeted NGS panel results, metastatic gastric cancer patients with gene amplifications will receive either anti-EGFR antibody (GC-1118) in combination with weekly paclitaxel as a second-line therapy.

Detailed Description

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Participants will receive each treatment if the gastric cancer tissue sample reveals either EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Conditions

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Adenocarcinoma of the Stomach

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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anti-EGFR

Participants will receive GC-1118 in combination with weekly paclitaxel.

Group Type EXPERIMENTAL

Anti-EGFR antibody in combination with weekly paclitaxel

Intervention Type DRUG

Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy

Interventions

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Anti-EGFR antibody in combination with weekly paclitaxel

Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy

Intervention Type DRUG

Other Intervention Names

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GC-1118 in combination with weekly paclitaxel

Eligibility Criteria

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Inclusion Criteria

1. Histologically-proven gastric and gastroesophageal junction adenocarcinoma
2. Refractory to first-line chemotherapy for metastatic disease
3. Presence of at least 1 measurable lesion according to RECIST version 1.1
4. EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Exclusion Criteria

1.Prior exposure to taxane or EGFR-targeted therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korean Cancer Study Group

OTHER

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hark Kyun Kim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hark K Kim, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hark K Kim, M.D.,Ph.D

Role: CONTACT

+82-31-920-2238

Facility Contacts

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Hark K Kim, MD,PhD

Role: primary

+82-31-920-2238

Hyegyung Chang, RN

Role: backup

+82-31-920-2233

Other Identifiers

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31973

Identifier Type: -

Identifier Source: org_study_id

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