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Recruiting NCT07436741

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

Phase III Interventional Pancreatic Cancer, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: surufatinib + gemcitabine + nab-paclitaxel, gemcitabine + nab-paclitaxel.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Adult. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Surgical complete resection rate (R0) [Time frame: about 1 year]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07436741 · HMPL-012-SPRING-P109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗