Surufatinib Plus Gemcitabine and Nab-paclitaxel vs. Gemcitabine Plus Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable Pancreatic Cancer
A Prospective, Randomized, Controlled, Multi-center Clinical Trial of Surufatinib Combined With Gemcitabine and Nab-paclitaxel Versus Gemcitabine Combined With Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable Pancreatic Cancer
1 other identifier
interventional
106
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2026
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedStudy Start
First participant enrolled
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
July 10, 2026
February 1, 2026
2.5 years
February 22, 2026
July 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical complete resection rate (R0)
This is a complete macroscopic resection of the gross tumor with negative surgical margins
about 1 year
Secondary Outcomes (7)
Event-free survival (EFS)
about 2 years
Objective Response Rate (ORR)
about 1 year
Disease Control Rate (DCR)
about 1 year
Downstaging Rate
about 1 year
Pathological complete response (pCR) rate
about 1 year
- +2 more secondary outcomes
Study Arms (2)
SUR+AG
EXPERIMENTALSurufatinib Plus Gemcitabine and Nab-paclitaxel
AG
ACTIVE COMPARATORGemcitabine Plus Nab-paclitaxel
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed high-risk resectable or borderline resectable pancreatic cancer;
- years old (including 18 and 75 years old);
- No BRCA1/2 or PALB2 mutation;
- No previous pancreatic cancer resection, systemic therapy, or local radiation therapy;
- Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- Life expectancy ≥ 6 months;
- At least one measurable lesion according to RECIST version 1.1;
- Adequate organ and bone marrow functions;
- Women of childbearing age need to take effective contraceptive measures.
You may not qualify if:
- With distant metastasis;
- Have received blood transfusion treatment, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;
- Have received any surgery or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture and drainage, etc.);
- Allergic to the study drug or any of its adjuvants;
- Researchers judged clinically significant electrolyte abnormalities;
- History of serious cardiovascular and cerebrovascular diseases;
- With active ulcer, intestinal perforation and intestinal obstruction;
- Uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture according to the judgment of the investigator);
- Clinically significant electrolyte abnormalities judged by researchers;
- With active bleeding or obvious evidence of bleeding tendency;
- Hypertension that cannot be controlled by drugs: systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 100 mmHg;
- Women who are pregnant or lactating;
- Urinary protein ≥ ++, or the 24-hour urine protein quantification is greater than 1.0g;
- Concurrent tumors within 5 years (except treated cervical carcinoma in situ, basal cell carcinoma);
- Any disease or state that affects the absorption of drugs, or the subject cannot take oral drugs;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000, China
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jihui Hao, M.D.
Tianjin Medical University Cancer Institute and Hospital
- PRINCIPAL INVESTIGATOR
Song Gao, M.D.
Tianjin Medical University Cancer Institute and Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2026
First Posted
February 27, 2026
Study Start
March 3, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
March 1, 2030
Last Updated
July 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share