Adenocarcinoma of the Stomach
Conditions
Keywords
EGFR
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
Interventions
DRUGAnti-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
Sponsors
Korean Cancer Study Group
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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 Key
Exclusion criteria
1.Prior exposure to taxane or EGFR-targeted therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Response rate will be assessed at 8 weeks. | Response rate will be assessed using CT/MRI according to RECIST v1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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 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. |
Countries
South Korea
Contacts
Primary ContactHark K Kim, M.D.,Ph.D
Outcome results
None listed