Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05504720 | Evaluating Pembrolizumab, Trastuzumab and FLOT as Perioperative Treatment of HER2-positive, Localized Esophagogastric Adenocarcinoma | PHASE2 | ACTIVE NOT_RECRUITING | 31 | — | — | Feb 13, 2023 | Dec 1, 2027 | Jun 6, 2025 | 13 | Germany |
Disease-free survival is defined as the proportion of patients being tumor/disease free and alive 2 years after enrolment.
The pCR rate is defined as the absence of residual tumor based on evaluation of the resected esophagogastric specimen in the primary tumor by local pathology.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab Trastuzumab | EXPERIMENTAL | Single arm with pembrolizumab (200 mg flat dose over 30 min IV) on day 1, 22 and 43 plus trastuzumab (loading dose 8 mg/kg IV over 90 min at day 1 and maintenance dose 6 mg/kg IV over 30 min) on day 22 and 43 plus FLOT in four 2-week treatment cycles prior to undergoing surgery. Following surgery, patients will receive four further 2-week cycles of pembrolizumab+trastuzumab + FLOT followed by pembrolizumab (200 mg flat dose) and trastuzumab (6 mg/kg) alone for up to 11 further cycles (Q3W). |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | 200 mg flat dose, IV, over 30 minutes; day 1, 22, 43 (8 weeks) pre- and post-surgery, followed by post chemotherapy phase day 1 q3w for 11 cycles; max. 17 applications |
| Trastuzumab | DRUG | loading dose 8 mg/kg IV over 90 min: day 1 pre- and post-surgery; maintenance dose 6 mg/kg IV over 30 min: Day 22, 43 pre- and post-surgery; followed by 6 mg/kg post chemotherapy phase, day 1 q3w for 11 cycles; max. 17 applications |
| FLOT | DRUG | Docetaxel 50 mg/m² IV over 1 hour plus Oxaliplatin 85 mg/m² IV over 2 hours plus Folinic Acid 200 mg/m² IV over 1 hour plus 5-FU 2600 mg/m² IV over 24 hours every 2 weeks (day 1, 15, 29, 43) for 8 weeks pre- and 8 weeks post-surgery |
Inclusion Criteria: 1. The participant provides written informed consent for the trial. 2. Male/female\* participants who are at least 18 years of age on the day of signing informed consent. \*There are no data that indicate special gender distribution. Therefore, patients will be enrolled in t...