Surufatinib Plus Gemcitabine and Nab-paclitaxel vs. Gemcitabine Plus Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable Pancreatic Cancer
NCT07436741 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2026-07-10
Summary
To explore the efficacy and safety of surufatinib in combination with AG regimen verus AG regimen as peri-operative treatment in high - risk resectable or borderline resectable pancreatic cancer
Conditions
- Pancreatic Cancer, Adult
Interventions
- DRUG
-
surufatinib + gemcitabine + nab-paclitaxel
Neoadjuvant therapy: Surufatinib: 250mg, QD po; Nab-paclitaxel: 125mg/m2, I.V., D1/8, Q3W; Gemcitabine: 1000/m2,I.V., D1/8, Q3W. Adjuvant therapy: Gemcitabine: 1000/m2,I.V., D1/8, Q3W; Capecitabine: 1650-2000mg/(m2·d) bid, po, d1-14, Q3W.
- DRUG
-
gemcitabine + nab-paclitaxel
Neoadjuvant therapy: Nab-paclitaxel: 125mg/m2, I.V., D1/8, Q3W; Gemcitabine: 1000/m2,I.V., D1/8, Q3W. Adjuvant therapy: Gemcitabine: 1000/m2,I.V., D1/8, Q3W; Capecitabine: 1650-2000mg/(m2·d) bid, po, d1-14, Q3W.
Sponsors & Collaborators
-
Tianjin Medical University Cancer Institute and Hospital
lead OTHER
Principal Investigators
-
Jihui Hao, M.D. · Tianjin Medical University Cancer Institute and Hospital
-
Song Gao, M.D. · Tianjin Medical University Cancer Institute and Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-03
- Primary Completion
- 2028-09-30
- Completion
- 2030-03-31
Countries
- China
Study Locations
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