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EGFR-targeted Therapy for Gastric Cancer

Phase 2
Recruiting
Conditions
Adenocarcinoma of the Stomach
Interventions
Drug: Anti-EGFR antibody in combination with weekly paclitaxel
Registration Number
NCT04077255
Lead Sponsor
National Cancer Center, Korea
Brief Summary

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

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

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
19
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
anti-EGFRAnti-EGFR antibody in combination with weekly paclitaxelParticipants will receive GC-1118 in combination with weekly paclitaxel.
Primary Outcome Measures
NameTimeMethod
Response rateResponse rate will be assessed at 8 weeks.

Response rate will be assessed using CT/MRI according to RECIST v1.1.

Secondary Outcome Measures
NameTimeMethod
Progression-free survivalFrom date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed up to 1 year.

Time from date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed.

Trial Locations

Locations (1)

National Cancer Center

🇰🇷

Goyang, Gyeonggi, Korea, Republic of

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