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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06621095 | Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer (ALTER-PA-001) | PHASE2 | NOT YET_RECRUITING | 104 | — | — | Oct 30, 2024 | Dec 31, 2026 | Oct 1, 2024 | 1 | China |
The proportion of patients with complete response or partial response, using RESIST v1.1
| Arm | Type | Description |
|---|---|---|
| anlotinib + benmelstobart + nab-paclitaxel + gemcitabine | EXPERIMENTAL | Initial treatment: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): anlotinib + benmelstobart + gemcitabine. |
| nab-paclitaxel + gemcitabine | ACTIVE_COMPARATOR | Initial treatment: nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): gemcitabine. |
| Name | Type | Description |
|---|---|---|
| anlotinib + benmelstobart + nab-paclitaxel + gemcitabine | DRUG | 1. Before 8 cycles, anlotinib 8mg, po.qd, d1-14; benmelstobart: 1200mg, I.V., D1, Q3W; nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The above schemes are repeated every three weeks. 2. After 8 cycles, the regimen is changed to anlotinib 8mg, po.qd, d1-14; benmelstobart: 1200mg, I.V., D1, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity. |
| nab-paclitaxel + gemcitabine | DRUG | 1. Before 8 cycles, nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The above schemes are repeated every three weeks. 2. After 8 cycles, the regimen is changed to gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity. |
Inclusion Criteria: * 18-75 years old (including 18 and 75 years old); * Histologically or cytologically confirmed diagnosis of metastatic pancreatic cancer; * No prior systemic therapy for metastatic pancreatic cancer (allowable circumstances for inclusion include recurrence more than 6 months aft...