Pancreatic Cancer, AdultPhase 3NCT07436741
Surufatinib Plus Gemcitabine and Nab-paclitaxel vs. Gemcitabine Plus Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable Pancreatic Cancer
A Phase 3 study testing surufatinib + gemcitabine + nab-paclitaxel and gemcitabine + nab-paclitaxel in people with Pancreatic Cancer, Adult, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Adult
- What is being tested?
- surufatinib + gemcitabine + nab-paclitaxel and gemcitabine + nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2026to Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Song Gao, M.D. contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
Jihui Hao, M.D., 022-23524155, ec_tjcih@126.com
Song Gao, M.D.
About this study
Official title: 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
- Conditions
- Pancreatic Cancer, Adult
- Being tested
- surufatinib + gemcitabine + nab-paclitaxel, gemcitabine + nab-paclitaxel
- Medical subject headings
- Pancreatic cancer, adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surufatinib + gemcitabine + nab-paclitaxelDrug
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.
gemcitabine + nab-paclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SUR+AG | Experimental | Surufatinib Plus Gemcitabine and Nab-paclitaxel Receives: Drug: surufatinib + gemcitabine + nab-paclitaxel |
| AG | Active comparator | Gemcitabine Plus Nab-paclitaxel Receives: Drug: gemcitabine + nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complete resection rate (R0)
This is a complete macroscopic resection of the gross tumor with negative surgical margins
Measured: about 1 year
Secondary outcomes (7)
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
Measured: about 2 years
Objective Response Rate (ORR)
ORR= Complete response rate + partial response rate
Measured: about 1 year
Disease Control Rate (DCR)
DCR= Complete response rate + partial response rate + disease stable rate
Measured: about 1 year
Downstaging Rate
To determine the rate of downstaging after preoperative therapy
Measured: about 1 year
Pathological complete response (pCR) rate
pCR is defined as the absence of residual tumor cells in the pathological examination after resection
Measured: about 1 year
Overall survival (OS)
Time from randomization to death
Measured: about 5 years
Adverse events (AEs)
treatment-related adverse events and serious adverse events as assessed by CTCAE v6.0
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start3 Mar 2026
- Primary completionSep 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer, AdultStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jihui Hao, M.D., Principal investigator, Tianjin Medical University Cancer Institute and HospitalSong Gao, M.D., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436741
- Sponsor's protocol ID
- HMPL-012-SPRING-P109
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07436741
- Acronym / sponsor ID
- HMPL-012-SPRING-P109
- Conditions
- Pancreatic Cancer, Adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUR+AG | Experimental | Drug: surufatinib + gemcitabine + nab-paclitaxelSurufatinib Plus Gemcitabine and Nab-paclitaxel |
| AG | Active comparator | Drug: gemcitabine + nab-paclitaxelGemcitabine Plus Nab-paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surufatinib + gemcitabine + nab-paclitaxelNeoadjuvant 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 | SUR+AG |
| gemcitabine + nab-paclitaxelNeoadjuvant 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. | Drug | AG |
Primary outcome
Surgical complete resection rate (R0)
Time frame: about 1 year
This is a complete macroscopic resection of the gross tumor with negative surgical margins
7 secondary outcomes
Event-free survival (EFS)
Time frame: about 2 years
Objective Response Rate (ORR)
Time frame: about 1 year
Disease Control Rate (DCR)
Time frame: about 1 year
Downstaging Rate
Time frame: about 1 year
Pathological complete response (pCR) rate
Time frame: about 1 year
Overall survival (OS)
Time frame: about 5 years
Adverse events (AEs)
Time frame: about 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Song Gao, M.D. contact
Jihui Hao, M.D. principal investigator
Tianjin Medical University Cancer Institute and Hospital
Song Gao, M.D. principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing surufatinib + gemcitabine + nab-paclitaxel and gemcitabine + nab-paclitaxel in people with Pancreatic Cancer, Adult, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihui Hao, M.D. (022-23524155, ec_tjcih@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complete resection rate (R0) (time frame: about 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.