Advanced gastric adenocarcinoma and intended curative gastrectomy (R0 resection). MedDRA version: 8.1 Level: HLT Classification code 10017812 Term: Gastric neoplasms malignant
Conditions
Sponsors
Fresenius Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent 2. Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3) 3. Intended curative gastrectomy (en-bloc-R0-resection considering the standardized D2-schedule) 4. Serosal infiltration (T3/T4, N+/-, M0) or T2b, N+/-, M0 confirmed by immediate section with histopathologic assessment during surgery 5. Male or female at an age of 18 years or older 6. Karnofsky index >/= 70 7. Negative pregnancy blood test at screening in women with childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of distant metastases 2. Macroscopic and microscopic*) residual tumor present after surgery 3. Pancreas resection (also partial) or thoracotomy 4. Exposure to prior cancer therapy (surgery, chemo- or radio-therapy) or planned adjuvant chemo- or radiotherapy of the current gastric cancer 5. Previous treatment with non-humanized mouse or rat monoclonal antibodies 6. Known/suspected hypersensitivity to catumaxomab or similar antibodies 7. Any cancer disease or any cancer treatments within the last 5 years 8. Presence of constant immunosuppressive therapy within the last 28 days prior to the first administration of catumaxomab 9. Presence of bilateral pleural effusion or hypalbuminemia associated with hypovolemia and hypotension 10. Presence of symptomatic heart failure or occlusive arterial diseases 11. Inadequate renal function (Creatinine >1.5 x ULN), 12. Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin = 1.5 x ULN) 13. Platelets <75000 cells/mm3; absolute neutrophil count <1500 cells/mm3 14. Patient had a bowel obstruction within the last 30 days 15. Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least three months after the last infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms) 16. Presence of any acute or chronic systemic infection 17. Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study 18. Patient is an employee of any involved study investigator or any involved institution including the study sponsor 19. Parallel participation in another clinical trial or previous participation in this study 20. Treatment with another investigational product during this study or during the last 30 days prior to study start *): according to the results of the immediate section during surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety, tolerability and feasibility.;Secondary Objective: Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information secondary on relevant efficacy parameters.;Primary end point(s): - Frequency, relationship and seriousness of adverse events (AEs) - Clinically relevant laboratory results (hematology with differential count, clinical chemistry, coagulation tests, DABA and urinalysis), - Vital functions (SBP/DBP, HR, T°) - Electrocardiogram (ECG) - Physical examination - Number and duration of hospitalizations - Peri- and postoperative outcome | — |
Countries
Germany
Outcome results
None listed