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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05615818 | Personalized Medicine for Advanced Biliary Cancer Patients | PHASE3 | RECRUITING | 800 | — | — | Jul 18, 2024 | Jun 1, 2028 | May 19, 2026 | 69 | Belgium, France +1 |
Time from randomisation to the first documented progression of disease (PD) as assessed by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | Molecular targeted therapy matched to genetic alteration carried by the tumour |
| Control | ACTIVE_COMPARATOR | Continued standard of care treatment for first-line biliary tract cancer |
| Name | Type | Description |
|---|---|---|
| Futibatinib | DRUG | Dose 20 mg once a day (QD) |
| Ivosidenib | DRUG | Dose 500 mg QD |
| Zanidatamab | DRUG | Dose: Patients \< 70 kg: 1800 mg every 3 weeks (Q3W), Patients ≥ 70 kg: 2400 mg Q3W |
| Trastuzumab | DRUG | Loading dose 8 mg/kg, then 6 mg/kg Q3W (Combination with neratinib) |
| Neratinib | DRUG | Dose: 240 mg QD (combination with trastuzumab) |
| Encorafenib | DRUG | Dose: 450 mg QD (Combination with binimetinib) |
| Binimetinib | DRUG | Dose: 45 mg twice a day (BID) (Combination with encorafenib) |
| Niraparib | DRUG | Dose: 200 mg QD or 300 mg QD |
| Cisplatin | DRUG | Dose: 25 mg/m2 IV on days 1 and 8 Q3W (CISGEM) |
| Gemcitabine | DRUG | Dose: 1000 mg/m2 IV on days 1 and 8 Q3W (CISGEM) |
SCREENING PHASE Inclusion Criteria: 1. Signed a written informed consent form prior to any trial specific procedures (Consent #1) 2. Histologically-proven intrahepatic, perihilar or distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded) 3. De novo or recurrent, locally ...