Back to resultsSHR6390 Plus Nab-paclitaxel and Gemcitabine in Advanced/Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR6390
Nab-paclitaxel
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Male or female of 18 to 75 years old;
- Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm);
- Subjects are naïve to systemic treatment;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥12 weeks;
- Adequate organ performance based on laboratory blood tests;
- The toxicity of the previous treatment has been restored to ≤1 level (if there is surgery, the wound has completely healed);
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
- Normal swallowing function;
- Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.
Exclusion Criteria:
- Had other active malignant tumors within 5 years before entering the study;
- Confirmed or suspicious new metastatic lesion in brain;
- Subjects are allergy to experimental drugs or any excipients;
- Coagulation disorders (INR>1.5, APTT>ULN);
- Severe pleural effusion or ascites;
- Severe and uncontrolled medical diseases, acute infections; recent history of major surgery for myocardial infarction (within 3 months);
- Subjects combined with other anti-tumor drugs;
- Chronic diarrhea or intestinal obstruction;
- Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures;
- Subjects in any trial drug treatment;
- Severe mental disorder;
- Other situations that investigators considered should be excluded.
Sites / Locations
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AG+SHR6390
Arm Description
Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1.
Adverse Events (AEs)
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as the time from the first drugs administration to the date of death due to any cause or the last follow ship.
Progression Free Survival (PFS)
PFS is defined as the time from the first drugs administration to the date of disease progression or the last follow ship.
Disease Control Rate (DCR)
DCR is defined as the rate of participants who have achieved complete response, partial response and stable disease.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05185869
Brief Title
SHR6390 Plus Nab-paclitaxel and Gemcitabine in Advanced/Metastatic Pancreatic Cancer
Official Title
A Phase II Study of SHR6390 Plus Nab-paclitaxel and Gemcitabine in Unresectable Advanced/Metastatic Pancreatic Ductal Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin 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
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.
Detailed Description
This is an open-label, prospective, single-center, single-arm, Simon's two-stage design phase II study for unresectable advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) subjects treated with SHR6390 plus nab-paclitaxel and gemcitabine.
In this research study, the main objectives include:
Evaluate objective response rate in patients with pancreatic cancer receiving SHR6390 plus nab-paclitaxel and gemcitabine.
Assess adverse side effects associated with the combination of SHR6390 with nab-paclitaxel and gemcitabine.
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
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AG+SHR6390
Arm Type
Experimental
Arm Description
Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine
Intervention Type
Drug
Intervention Name(s)
SHR6390
Intervention Description
SHR6390, Oral Administration
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Paclitaxel-albumin, Intravenous Injection
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine, Intravenous Injection
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1.
Time Frame
Up to 2 years.
Title
Adverse Events (AEs)
Description
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
From the first drugs administration to within 30 days for the last treatment.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the first drugs administration to the date of death due to any cause or the last follow ship.
Time Frame
Up to 2 years.
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from the first drugs administration to the date of disease progression or the last follow ship.
Time Frame
Up to 2 years.
Title
Disease Control Rate (DCR)
Description
DCR is defined as the rate of participants who have achieved complete response, partial response and stable disease.
Time Frame
Up to 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:
Male or female of 18 to 75 years old;
Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm);
Subjects are naïve to systemic treatment;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Life expectancy ≥12 weeks;
Adequate organ performance based on laboratory blood tests;
The toxicity of the previous treatment has been restored to ≤1 level (if there is surgery, the wound has completely healed);
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
Normal swallowing function;
Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.
Exclusion Criteria:
Had other active malignant tumors within 5 years before entering the study;
Confirmed or suspicious new metastatic lesion in brain;
Subjects are allergy to experimental drugs or any excipients;
Coagulation disorders (INR>1.5, APTT>ULN);
Severe pleural effusion or ascites;
Severe and uncontrolled medical diseases, acute infections; recent history of major surgery for myocardial infarction (within 3 months);
Subjects combined with other anti-tumor drugs;
Chronic diarrhea or intestinal obstruction;
Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures;
Subjects in any trial drug treatment;
Severe mental disorder;
Other situations that investigators considered should be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baiyong Shen, Ph.D&M.D
Phone
008613901943778
Email
shenby@shsmu.edu.cn
Facility Information:
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baiyong Shen, Ph.D&M.D
Phone
008602164370045
First Name & Middle Initial & Last Name & Degree
Baiyong Shen, Ph.D&M.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SHR6390 Plus Nab-paclitaxel and Gemcitabine in Advanced/Metastatic Pancreatic Cancer
We'll reach out to this number within 24 hrs