Surufatinib Plus Gemcitabine and Nab-paclitaxel vs. Gemcitabine Plus Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable Pancreatic Cancer

February 22, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
        • Contact:
          • Song Gao, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical complete resection rate (R0)
Time Frame: about 1 year
This is a complete macroscopic resection of the gross tumor with negative surgical margins
about 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS)
Time Frame: about 2 years
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)
Time Frame: about 1 year
ORR= Complete response rate + partial response rate
about 1 year
Disease Control Rate (DCR)
Time Frame: about 1 year
DCR= Complete response rate + partial response rate + disease stable rate
about 1 year
Downstaging Rate
Time Frame: about 1 year
To determine the rate of downstaging after preoperative therapy
about 1 year
Pathological complete response (pCR) rate
Time Frame: about 1 year
pCR is defined as the absence of residual tumor cells in the pathological examination after resection
about 1 year
Overall survival (OS)
Time Frame: about 5 years
Time from randomization to death
about 5 years
Adverse events (AEs)
Time Frame: about 2 years
treatment-related adverse events and serious adverse events as assessed by CTCAE v6.0
about 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University Cancer Institute and Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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