Gastric or Gastroesophageal Junction(GEJ) Adenocarcinoma
Conditions
Brief summary
A phase II clinical study of trastuzumab in combination with capecitabine and cisplatin (XP) in patients with tissue HER2-negative but serum HER2-positive advanced gastric cancer
Detailed description
3-weekly/ 1cycle treatment * Trastuzumab intravenous administration at a loading dose of 8 mg/kg on day 1 followed by 6 mg/kg every 3 weeks * Capecitabine oral administration at a dose of 1000 mg/m2 twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15) * Cisplatin intravenous administration at a dose of 80 mg/m2 on day 1
Interventions
DRUGTrastuzumab, Capecitabine and Cisplatin
* Trastuzumab intravenous administration at a loading dose of 8 mg/kg on day 1 followed by 6 mg/kg every 3 weeks * Capecitabine oral administration at a dose of 1000 mg/m2 twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15) * Cisplatin intravenous administration at a dose of 80 mg/m2 on day 1
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with inoperable, locally-advanced or recurrent and/or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are not eligible for curative therapy and are histologically diagnosed. 2. Diseases measurable according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) using imaging technique (CT or MRI). 3. Tissue HER2-negative tumors (primary or metastatic tumors) defined as IHC2+ and FISH- or IHC 0 or 1+ according to gastric cancer assessment system for HER2 (see Annex 12.5). 4. ECOG Performance status 0, 1 or 2 (see Annex 12.1). 5. Survival for at least 3 months should be possible. 6. Appropriate bone marrow, renal, and hepatic functions. General inclusion criteria 7. Males or females aged 19 years. 8. Patients should sign the informed consent form (ICF).
Exclusion criteria
1. Patients who previously received chemotherapy for advanced/metastatic diseases (adjuvant/neoadjuvant chemotherapy, completed at least 6 months prior to enrollment in this clinical study, is permitted, but platinum-based adjuvant/neoadjuvant chemotherapy is not permitted). 2. Patients with a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome (e.g., patients who underwent partial or total gastric resection can participate in this clinical study, but patients equipped with a jejunostomy tube cannot participate). 3. Patients with active (serious or uncontrolled) gastrointestinal bleeding. 4. Patients with relevant toxicities remaining following previous curative therapy (except for alopecia). For example, neurotoxicity ≥ grade 2 based on NCI-CTCAE version 5.0. 5. Patients with a history of other malignant diseases based on the date of complete recovery within 5 years prior to the initiation of treatment in this clinical study (except for in-situ cervical cancer and basal cell carcinoma). Hematologic, blood chemistry, and organ functions 6. Neutrophil count \< 1.5 × 109/L, or platelet count \< 100 × 109/L. 7. Serum bilirubin\> 1.5 × upper limit of normal (ULN); or AST or ALT \> 2.5 × ULN (or \> 5 × ULN hepatic metastasis patients); or alkaline phosphatase \> 2.5 × ULN (or \> 5 × ULN hepatic metastasis patients, or \> 10 × ULN hepatic metastasis-free bone metastasis patients); or, albumin \< 2.5 g/dL. 8. Creatinine clearance \< 60 mL/min. However, creatinine clearance is first calculated using the Cockroft-Gault formula, and if the value is \< 60ml/min, a 24hr urine collection test is carried out. Subject enrollment is possible only when creatinine clearance is ≥ 60mL/min. Other investigational product-associated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (Overall tumor response) | 2 years | Overall tumor response (responder/non-responder) which is a primary efficacy endpoint: is defined as the maximal response among confirmed cases of complete response (CR) or partial response (PR) determined by definite radiological assessment of target and nontarget lesions in accordance with RECIST criteria version 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 2 years | Time from the start date of chemotherapy to the date of disease progression or death of any cause which comes first |
| Duration of response | 2 years | Time from the date of tumor response by RECIST version 1.1 to the date of disease progression |
| Overall Survival | 2 years | Time from the start date of chemotherapy to the date of death of any cause |
| Time to disease progression | 2 years | Time from the start date of chemotherapy to the date of disease progression |
| Safety(Toxicity profile) | 2 years | Assessed by NCI CTCAE version 5.0 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORMin-Hee Ryu, MD, PhD
Asan Medical Center
Outcome results
None listed