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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02678182 | Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial | PHASE2 | ACTIVE NOT_RECRUITING | 494 | — | — | Feb 1, 2015 | Jun 1, 2027 | Jun 10, 2025 | 1 | United Kingdom |
The progression free survival will be calculated from the date of randomisation to the date of disease progression according to RECIST 1.1 criteria or death from any cause, whichever comes first. In HER 2 negative patients the PFS will be compared between the standard Arm (A1) and capecitabine (A2) and then separately between standard arm (A1) and MEDI 4736 (A3), or standard arm (A1) and Rucaparib (A4), or standard arm (A1) and Ramucirumab (A5).
| Arm | Type | Description |
|---|---|---|
| A1: Surveillance | NO_INTERVENTION | Patients in this Arm will follow current UK standard of care for this setting and will be reviewed every 4 weeks |
| Arm A2: Capecitabine Maintenance | EXPERIMENTAL | 1250 mg/M2/DAY on days 1-21 |
| Arm A3: MEDI4736 (Durvalumab) | EXPERIMENTAL | IV treatment on day 1 +15, on a 28 day cycle. |
| Arm B1: Trastuzumab Maintenance | ACTIVE_COMPARATOR | 6mg/kg on day 1 every 21 days |
| Arm A4: Rucaparib | EXPERIMENTAL | 600mg PO twice daily |
| Arm A5: Capecitabine and Ramucirumab | EXPERIMENTAL | capecitabine 1250 mg/m2/day PO in two divided doses continuously from days 1-21 of each 21 day cycle (see section 12) and ramucirumab 8mg/kg IV day 1 and day 8 |
| Name | Type | Description |
|---|---|---|
| Capecitabine | DRUG | 1250 mg/m2/day, 21 day cycle |
| MEDI4736 (Durvalumab) | DRUG | IV treatment on days 1\&15 of 28 day cycle |
| Trastuzumab | DRUG | 6mg/kg on day 1 cycle every 21 days |
| Rucaparib | DRUG | 600mg PO twice daily |
| Ramucirumab | DRUG | ramucirumab 8mg/kg IV day 1 and day 8 |
Inclusion Criteria - All Patients * Histologically verified inoperable locally advanced or metastatic adenocarcinoma of the oesophagus, oesophago-gastric junction, or stomach. * Completion of 18 weeks of first-line chemotherapy with either CX/ CAPOX or FOLFOX (HER2 negative) or CX/ CF + trastuzumab...