locally advanced resectable adenocarcinoma of the oesophagogastric junction or the stomach
Conditions
Brief summary
Primary Endpoint Phase III: Event-free survival EFS, defined as the time from randomization to disease progression or relapse after surgery or death from any cause, Primary Endpoint Phase II (exploratory): pCR or TRG 1a rate where pCR is defined as the absence of residual tumor based on evaluation of the resected esophagogastric specimen in the primary (as assessed by local pathology) and postoperative TNM (pTNM) stage according to the 8th version of the UICC classification (as assessed by local pathology) – both as exploratory endpoints
Detailed description
Rate of pathological complete responses (pCR, TRG1a) as assessed according to the Becker criteria, Rate of pathological complete and subtotal remission (pCR+pSR, TRG1a/b) as assessed according to the Becker criteria, R0 resection rate, Overall survival (OS) (Phase III only), OS and EFS in the subgroups of patients with PD-L1 CPS score ≥ 5 and ≥ 10 and patients with MSI (Phase III only), Safety (according to NCI-CTCAE V 4.03) and tolerability, Perioperative morbidity and mortality rates, ctDNA exploratory endpoints
Interventions
DRUGInjektionslösung
DRUGTecentriq 1 200 mg concentrate for solution for infusion
Sponsors
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint Phase III: Event-free survival EFS, defined as the time from randomization to disease progression or relapse after surgery or death from any cause, Primary Endpoint Phase II (exploratory): pCR or TRG 1a rate where pCR is defined as the absence of residual tumor based on evaluation of the resected esophagogastric specimen in the primary (as assessed by local pathology) and postoperative TNM (pTNM) stage according to the 8th version of the UICC classification (as assessed by local pathology) – both as exploratory endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of pathological complete responses (pCR, TRG1a) as assessed according to the Becker criteria, Rate of pathological complete and subtotal remission (pCR+pSR, TRG1a/b) as assessed according to the Becker criteria, R0 resection rate, Overall survival (OS) (Phase III only), OS and EFS in the subgroups of patients with PD-L1 CPS score ≥ 5 and ≥ 10 and patients with MSI (Phase III only), Safety (according to NCI-CTCAE V 4.03) and tolerability, Perioperative morbidity and mortality rates, ctDNA exploratory endpoints | — |
Countries
Germany
Outcome results
None listed