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NOT YET RECRUITING
NCT06621095
PHASE2

Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer (ALTER-PA-001)

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

This study is designed to explore the efficacy and safety of anlotinib combined with benmelstobart and AG (nab-paclitaxel and gemcitabine) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in metastatic pancreatic cancer.

Official title: Anlotinib Plus Benmelstobart and AG Versus AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial (ALTER-PA-001)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2024-10-30

Completion Date

2026-12-31

Last Updated

2024-10-01

Healthy Volunteers

No

Interventions

DRUG

anlotinib + benmelstobart + nab-paclitaxel + gemcitabine

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.

DRUG

nab-paclitaxel + gemcitabine

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.

Locations (1)

Renji hospital

Shanghai, Shanghai Municipality, China