The study is a open-label, single-arm, multicenter, phase Ib/II trial assessing the efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma
All eligible enrolled patients will receive:Sacituzumab-govitecan 10 mg/kg i.v. at day 1 and day 8 of each 21-day cycle (Q3W). Patients will receive the treatment for a maximum of 12 months or until disease progression, unacceptable toxicity or withdrawal of consent, whichever occurs first.The primary objective of the trial is to evaluate the efficacy (primary endpoint: Overall Response Rate ORR, complete response + partial response) of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma. The secondary objectives are to further characterize the efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma and to evaluate safety and tolerability of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma. Secondary endpoints comprise the assessment of Clinical benefit rate (CBR, complete response + partial response + stable disease), Progression-free survival (PFS), Overall survival (OS), ORR, CBR, PFS and OS in the subgroup of TROP-2 overexpression, toxiticy. In addition, tissue and blood samples will be analyzed to evaluate the TROP-2 expression during treatment with sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma. 56 patients will be enrolled in this trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
10 mg/kg i.v. at day 1 and day 8 of each 21-day cycle (Q3W) for max 17 cycles (max. 12 months treatment)
SCRI-CCCIT GmbH
Salzburg, Austria
Hämatologisch-Onkologische Praxis Eppendorf
Hamburg, Germany
Nationales Centrum für Tumorerkrankungen
Heidelberg, Germany
Universitätsklinikum Jena
Jena, Germany
Overall response rate
Objective response rate will be assessed according to RECIST v1.1. criteria and is defined as proportion of patients showing complete or partial response (CR+PR).
Time frame: up to 12 months
Clinical benefit rate
Clinical benefit rate will be assessed according to RECIST v1.1. criteria and is defined as proportion of patients showing complete response, partial response or stable disease (CR+PR+SD).
Time frame: up to 36 months
Progression-free survival (PFS)
Progression-free survival is defined as time from enrollment to the date of progression according to RECIST v1.1 or death due to any cause. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment.
Time frame: up to 36 months
Overall survival (OS)
Overall survival is defined as the time from enrollment to the date of death from any cause. Patients who have not experienced an event at the time of analysis will be censored at the date when the patient was last known to be alive.
Time frame: up to 36 months
Safety and toxicity
Safety and tolerability assessments will include physical examinations, clinical laboratory profile and continuous assessments of adverse events (AEs). AEs will be monitored throughout the trial and graded in severity according to the guidelines outlined in the NCI CTCAE v5.0.
Time frame: up to 13 months (max. 12 months treatment plus 30 days after last treatment)
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Universitätsklinikum Leipzig
Leipzig, Germany
Onkopraxis Probstheida
Leipzig, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Klinikum rechts der Isar der TU München
München, Germany