A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER… (NCT04309578) | Clinical Trial Compass
CompletedPhase 2
A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC
South Korea28 participantsStarted 2020-03-12
Plain-language 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
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Diseases measurable according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) using imaging technique (CT or MRI).
✓. 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).
✓. ECOG Performance status 0, 1 or 2 (see Annex 12.1).
✓. Survival for at least 3 months should be possible.
✓. Appropriate bone marrow, renal, and hepatic functions. General inclusion criteria
✓. Males or females aged 19 years.
✓. Patients should sign the informed consent form (ICF).
Exclusion criteria
✕. 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).
✕. 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).
. Patients with active (serious or uncontrolled) gastrointestinal bleeding.
✕. Patients with relevant toxicities remaining following previous curative therapy (except for alopecia). For example, neurotoxicity ≥ grade 2 based on NCI-CTCAE version 5.0.
✕. 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).
✕. 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.
✕. 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.