Efficacy And Safety Of Surufatinib Combined With Gemcitabine And Albumin-bound Paclitaxel In The Peri-operative Treatment Of Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: surufatinib + gemcitabine + nab-paclitaxel

HMPL-012-SPRING-P105

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-05-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-07-09
First Submitted that Met QC Criteria 2023-06-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-07-11
First Posted (ACTUAL) 2023-06-18	Results First Posted N/A	Last Verified 2023-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: surufatinib + gemcitabine + nab-paclitaxel	DRUG: surufatinib + gemcitabine + nab-paclitaxel 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: surufatinib + gemcitabine + nab-paclitaxel

DRUG: surufatinib + gemcitabine + nab-paclitaxel

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 Measures	Measure Description	Time Frame
Surgical complete resection rate (R0)	This is a complete macroscopic resection of the gross tumor with negative surgical margins	about 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR= Complete response rate + partial response rate	about 2 years
Disease Control Rate (DCR)	DCR= Complete response rate + partial response rate + disease stable rate	about 2 years
Downstaging Rate	To determine the rate of downstaging after preoperative therapy	about 2 years
Surgical Resection Rate	To determine the rate of surgical resection after preoperative therapy	about 2 years
Pathological complete response (pCR) rate	pCR is defined as the absence of residual tumor cells in the pathological examination after resection	about 2 years
Major pathological response (MPR)	MPR is defined as less than 10% residual tumor after neoadjuvant therapy	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.	about 5 years
Recurrence Free Survival (RFS)	RFS: from the initial date of neoadjuvant treatment to the first date of radiologic recurrence or death after perioperative treatment.	about 3 years
Disease-free survival (DFS)	DFS: from the initial date of neoadjuvant treatment to the date of disease recurrence or death, whichever is earlier.	about 3 years
Adverse events (AEs)	treatment-related adverse events and serious adverse events as assessed by CTCAE v5.0	about 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jihui Hao, M.D.

Phone Number: 022-23524155

Email: ec_tjcih@126.com

Study Contact Backup

Name: Song Gao, M.D.

Phone Number:

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Jihui Hao, M.D., Tianjin Medical University Cancer Institute and Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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