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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer, Adult
• Intervention / Treatment: Drug: surufatinib + gemcitabine + nab-paclitaxel; Drug: gemcitabine + nab-paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jihui Hao, M.D.; Phone Number: 022-23524155; Email: ec_tjcih@126.com
• Study Contact Backup: Name: Song Gao, M.D.; Email: foxgao2004@163.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300000
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Jihui Hao, M.D.; Phone Number: 022-23524155; Email: ec_tjcih@126.com
      • Contact: Song Gao, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed high-risk resectable or borderline resectable pancreatic cancer;
• 18-75 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.

Exclusion Criteria:

• 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;
• Known human immunodeficiency virus (HIV) infection;
• History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10^4/ml or >2000 IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×10^3/m); hepatitis and cirrhosis;
• Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not suitable for enrolling according to the judgment of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUR+AG; Surufatinib Plus Gemcitabine and Nab-paclitaxel	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.
Active Comparator: AG; Gemcitabine Plus Nab-paclitaxel	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complete resection rate (R0)	This is a complete macroscopic resection of the gross tumor with negative surgical margins	about 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival (EFS)	The time from randomization to the first event of disease progression that precluded surgery, local or distant recurrence, or death from any cause	about 2 years
Objective Response Rate (ORR)	ORR= Complete response rate + partial response rate	about 1 year
Disease Control Rate (DCR)	DCR= Complete response rate + partial response rate + disease stable rate	about 1 year
Downstaging Rate	To determine the rate of downstaging after preoperative therapy	about 1 year
Pathological complete response (pCR) rate	pCR is defined as the absence of residual tumor cells in the pathological examination after resection	about 1 year
Overall survival (OS)	Time from randomization to death	about 5 years
Adverse events (AEs)	treatment-related adverse events and serious adverse events as assessed by CTCAE v6.0	about 2 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pancreatic cancer, adult; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; 130-nm albumin-bound paclitaxel; surufatinib
• Other Study ID Numbers: HMPL-012-SPRING-P109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No