Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Pancreatic Cancer

NCT05908747 | Active Not Recruiting Phase 2

• 1 other identifier: HMPL-012-SPRING-P105
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Surgical complete resection rate (R0)

  This is a complete macroscopic resection of the gross tumor with negative surgical margins

  about 2 years

Secondary Outcomes (10)

• Objective Response Rate (ORR)

  about 2 years

• Disease Control Rate (DCR)

  about 2 years

• Downstaging Rate

  about 2 years

• Surgical Resection Rate

  about 2 years

• Pathological complete response (pCR) rate

  about 2 years

Study Arms (1)

surufatinib + gemcitabine + nab-paclitaxel

EXPERIMENTAL

Drug: surufatinib + gemcitabine + nab-paclitaxel

Interventions

surufatinib + gemcitabine + nab-paclitaxel DRUG

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

surufatinib + gemcitabine + nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%;
• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

surufatinib; Gemcitabine; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jihui Hao, M.D.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Song Gao, M.D.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 18, 2023
• Study Start: May 31, 2023
• Primary Completion: May 16, 2025
• Study Completion: May 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CN (1)