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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06245356 | Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer | PHASE2 | RECRUITING | 73 | — | — | Mar 21, 2025 | Oct 21, 2028 | Dec 10, 2025 | 21 | France |
The percentage of patients without specific toxicities defined as grade 3-4-5 digestive toxicities (diarrhoea and/or stomatitis) and grade 4-5 neutropenia or febrile neutropenia over the first 2 cycles of first-line metastatic treatment. Toxicities will be graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5), widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
| Arm | Type | Description |
|---|---|---|
| Colorectal adenocarcinoma | OTHER | Trifluridine/tipiracil in association with oxaliplatin with or without: * Panitumumab in RAS wild type tumors * Bevacizumab in RAS wild type of right colon or RAS mutated tumors |
| Gastroesophageal adenocarcinoma | OTHER | Trifluridine/tipiracil in association with oxaliplatin with or without: * Trastuzumab in HER2-positive tumors (3+ IHC or 2+/FISH+) * Nivolumab if CPS≥5 and HER2-negative tumors |
| Name | Type | Description |
|---|---|---|
| Lonsurf | DRUG | Trifluridine/tipiracil orally 35 mg/m²/dose (D1-D5 twice daily, D1=D15) |
| Oxaliplatin | DRUG | Oxaliplatin intravenous injection 85 mg/m² every 2 weeks (D1=D15) |
| Panitumumab | DRUG | Panitumumab intravenous injection 6 mg/kg (D1=D15) |
| Bevacizumab | DRUG | Bevacizumab intravenous injection 5 mg/kg (D1=D15) |
| Trastuzumab | DRUG | Trastuzumab intravenous injection 4 mg/kg (D1=D15) |
| Nivolumab | DRUG | Nivolumab intravenous injection 240 mg (D1=D15) |
Inclusion Criteria: 1. Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in w...