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

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
surufatinib + gemcitabine + nab-paclitaxel
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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. 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: -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; 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.

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surufatinib + gemcitabine + nab-paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

Surgical complete resection rate (R0)
This is a complete macroscopic resection of the gross tumor with negative surgical margins

Secondary Outcome Measures

Objective Response Rate (ORR)
ORR= Complete response rate + partial response rate
Disease Control Rate (DCR)
DCR= Complete response rate + partial response rate + disease stable rate
Downstaging Rate
To determine the rate of downstaging after preoperative therapy
Surgical Resection Rate
To determine the rate of surgical resection after preoperative therapy
Pathological complete response (pCR) rate
pCR is defined as the absence of residual tumor cells in the pathological examination after resection
Major pathological response (MPR)
MPR is defined as less than 10% residual tumor after neoadjuvant therapy
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.
Recurrence Free Survival (RFS)
RFS: from the initial date of neoadjuvant treatment to the first date of radiologic recurrence or death after perioperative treatment.
Disease-free survival (DFS)
DFS: from the initial date of neoadjuvant treatment to the date of disease recurrence or death, whichever is earlier.
Adverse events (AEs)
treatment-related adverse events and serious adverse events as assessed by CTCAE v5.0

Full Information

First Posted
May 24, 2023
Last Updated
July 9, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05908747
Brief Title
Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surufatinib + gemcitabine + nab-paclitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
surufatinib + gemcitabine + nab-paclitaxel
Intervention Description
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
Primary Outcome Measure Information:
Title
Surgical complete resection rate (R0)
Description
This is a complete macroscopic resection of the gross tumor with negative surgical margins
Time Frame
about 2 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR= Complete response rate + partial response rate
Time Frame
about 2 years
Title
Disease Control Rate (DCR)
Description
DCR= Complete response rate + partial response rate + disease stable rate
Time Frame
about 2 years
Title
Downstaging Rate
Description
To determine the rate of downstaging after preoperative therapy
Time Frame
about 2 years
Title
Surgical Resection Rate
Description
To determine the rate of surgical resection after preoperative therapy
Time Frame
about 2 years
Title
Pathological complete response (pCR) rate
Description
pCR is defined as the absence of residual tumor cells in the pathological examination after resection
Time Frame
about 2 years
Title
Major pathological response (MPR)
Description
MPR is defined as less than 10% residual tumor after neoadjuvant therapy
Time Frame
about 2 years
Title
Overall survival (OS)
Description
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.
Time Frame
about 5 years
Title
Recurrence Free Survival (RFS)
Description
RFS: from the initial date of neoadjuvant treatment to the first date of radiologic recurrence or death after perioperative treatment.
Time Frame
about 3 years
Title
Disease-free survival (DFS)
Description
DFS: from the initial date of neoadjuvant treatment to the date of disease recurrence or death, whichever is earlier.
Time Frame
about 3 years
Title
Adverse events (AEs)
Description
treatment-related adverse events and serious adverse events as assessed by CTCAE v5.0
Time Frame
about 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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. 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: -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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jihui Hao, M.D.
Phone
022-23524155
Email
ec_tjcih@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Song Gao, M.D.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihui Hao, M.D.
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Song Gao, M.D.
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jihui Hao, MD
Phone
022-23524155
Email
ec_tjcih@126.com
First Name & Middle Initial & Last Name & Degree
Song Gao, MD

12. IPD Sharing Statement

Learn more about this trial

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

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