Pancreatic CancerPhase 2NCT05908747
Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Pancreatic Cancer
A Phase 2 study testing surufatinib + gemcitabine + nab-paclitaxel in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is designed to explore the efficacy and safety of surufatinib combined with gemcitabine and nab-paclitaxel as peri-operative treatment in locally advanced 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
- What is being tested?
- surufatinib + gemcitabine + nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2023to 28 Jun 2026
- Phase
- Phase 2
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 systematic treatment or radiotherapy;
- 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: -Absolute neutrophil count≥1.5x10^9/L; -Platelet count≥100x10^9/L; -Hemoglobin≥9g/dL; -Serum bilirubin≤1.5x the upper limit of normal (ULN); -Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5x ULN; -Serum creatinine≤1.5x ULN or endogenous creatinine clearance rate ≥ 60ml / min; -INR≤1.5×ULN, PT and APTT≤1.5×ULN；
- 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: -Cerebrovascular accident (excluding lacunar cerebral infarction, minor cerebral ischemia or transient ischemic attack), myocardial infarction, unstable angina pectoris, and poorly controlled arrhythmia (including QTc interval ≥ 450ms for male and ≥ 470ms for female) occurred within 6 months before the first administration of the study drug (QTc interval was calculated by fridericia formula); -New York Heart Association (NYHA) cardiac function classification > grade II or left ventricular ejection fraction (LVEF) < 50%;
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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.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Locally Advanced or Borderline Resectable Pancreatic Cancer: An Exploratory Study
This study is designed to explore the efficacy and safety of surufatinib combined with gemcitabine and nab-paclitaxel as peri-operative treatment in locally advanced or borderline resectable pancreatic cancer.
Read the detailed description
This is a phase II, multi-centered, open-label study, aims to explore the efficacy and safety of surufatinib (250mg, qd po) combined with gemcitabine (1000mg/m2, I.V, d1/8/15, Q4W) and nab-paclitaxel (125mg/m2, I.V, d1/8/15, Q4W) as peri-operative treatment in locally advanced or borderline resectable pancreatic cancer. Potential therapeutic biomarkers will also be explored.
- Conditions
- Pancreatic Cancer
- Being tested
- surufatinib + gemcitabine + nab-paclitaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surufatinib + gemcitabine + nab-paclitaxelDrug
surufatinib: 250mg, QD po; nab-paclitaxel: 125mg/m2, I.V., D1/8/15, Q4W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1/8/15, Q4W
| Study group | Role | What they receive |
|---|---|---|
| surufatinib + gemcitabine + nab-paclitaxel | Experimental | Not described Receives: Drug: surufatinib + 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 2 years
Secondary outcomes (9)
Objective Response Rate (ORR)
ORR= Complete response rate + partial response rate
Measured: about 2 years
Disease Control Rate (DCR)
DCR= Complete response rate + partial response rate + disease stable rate
Measured: about 2 years
Downstaging Rate
To determine the rate of downstaging after preoperative therapy
Measured: about 2 years
Surgical Resection Rate
To determine the rate of surgical resection after preoperative therapy
Measured: about 2 years
Pathological complete response (pCR) rate
pCR is defined as the absence of residual tumor cells in the pathological examination after resection
Measured: about 2 years
Major pathological response (MPR)
MPR is defined as less than 10% residual tumor after neoadjuvant therapy
Measured: about 2 years
Overall survival (OS)
OS: from the initial date of neoadjuvant therapy to the date of death due to any cause. Patients without documentation of death at the time of analysis will be censored at the last follow-up date. Estimated using Kaplan-Meier method.
Measured: about 5 years
Disease-free survival (DFS)
DFS: from the date of surgery to the date of disease recurrence or death, whichever is earlier.
Measured: about 3 years
Adverse events (AEs)
treatment-related adverse events and serious adverse events as assessed by CTCAE v5.0
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 posted18 Jun 2023
- Study start31 May 2023
- Primary completion16 May 2025
- Study completion28 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- 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
- NCT05908747
- Sponsor's protocol ID
- HMPL-012-SPRING-P105
- Status last verified
- Feb 2026
- First submitted
- 24 May 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No