Drug Sensitivity Screening for Gastrointestinal Cancer
Primary Purpose
Gastrointestinal Cancer Metastatic
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Personalized drug sensitivity test
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Cancer Metastatic focused on measuring Personalized, Drug Sensitivity Test, Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Adult patients between 18 and 70 years old, male or female;
- Voluntary patient consent;
- Treatment-naïve, stage III/IV gastrointestinal cancer patients with pathology confirmation;
- According clinical researcher, patient has operable tumor lesion, and tumor tissue can be obtained through surgical removal;
- Good tolerability to standard chemotherapy regimen;
- ECOG status <3;
- Estimated survival time no less than 6 months;
- Patient has at least one measurable disease lesion (according to RECIST1.1).
Exclusion Criteria:
- Patient has received any prior anti-cancer treatment;
- Participated in any other clinical study within 6 months;
- Women currently breast feeding or pregnant;
- Severe liver or kidney function impairment (Live function: TBIL ≤1.5×ULN,ALT & AST≤2.5×ULN);
- Patients with liver metastasis ≤5.0×ULN;Kidney function:Cr ≤1.5×ULN and creatinine clearance rate≥ 50 mL/min (according to the Cockcroft-Gault formula);
- Patients with cognitive impairment, psychological disease, or poor compliance;
- Allergic to known chemotherapy ingredients;
- Other factors researchers deemed not suitable for study participation.
Sites / Locations
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stage III/IV gastrointestinal cancer patients
Arm Description
The study group (Personalized drug sensitivity test) was treated according to the physician's opinion. Tumor tissues are obtained during the surgery or via biopsy with informed consent, for the purpose of ex vivo assay.
Outcomes
Primary Outcome Measures
ex vivo Maximal Inhibition Index (MI)
The effectiveness of each therapeutic regimen was evaluated and quantified using the formula: Maximum Inhibition (MI)=N0/Nd, where N0 and Nd denotes the number of EpCAM+ EdU+ epithelial cells in the wells of control or withthe drug at concentration C0, respectively.
Secondary Outcome Measures
Disease Control Rate(DCR)after chemotherapy
Disease Control Rate(DCR)after chemotherapy.
Progression free survival (PFS) after chemotherapy
Progression free survival (PFS) after chemotherapy
Full Information
NCT ID
NCT04298489
First Posted
December 10, 2018
Last Updated
March 5, 2020
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT04298489
Brief Title
Drug Sensitivity Screening for Gastrointestinal Cancer
Official Title
Personalized Drug Sensitivity Test for Late Stage, Potentially Operable Gastrointestinal Cancer Using Patient Derived Primary Cell Culture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
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
Explore the clinical feasibility of using primary cell culture system to guide gastrointestinal cancer chemotherapy, and establish the correlation between ex vivo drug sensitivity and patient clinical response.
Study objectives: Personalized drug sensitivity test for late stage,potentially operable gastrointestinal cancer using patient derived primary cell culture.
Explore the clinical feasibility of using primary cell culture system to guide gastrointestinal cancer chemotherapy, and establish the correlation between ex vivo drug sensitivity and patient clinical response.
The study will collect primary tumor tissues from stage III/IV gastrointestinal cancer patients who underwent emergency surgeries, and then establish the primary tumor cell library for ex vivo chemotherapy drug sensitivity test in order to:
Compare the ex vivo Maximal Inhibition Index(MI) and Drug Sensitivity Index (DSI) with patient's Overall Response Rate (ORR)
Provide research support for future clinical treatment.
This ex vivo method applies to single or combination drug regimen, and does not require prior knowledge of the specific mechanism for individual patient's drug sensitivity. Previous research as well as literature studies support the close relationship between ex vivo drug sensitivity and in vivo drug response.
Detailed Description
The patient underwent surgery to remove tumor and agreed to take out the abdominal tumor specimens for research. A section of each sample was removed for the generation of PDX models as described early.The rest of the tumor cells were expanded using ex vivo drug sensitivity assay.
The drugs used in the study were 5-fluorouracil, Oxaliplatin, and irinotecan at C0 = 10 mM, 2.5 mM and 0.02 mM, respectively. They were applied either as single agents or in combinations of 5-fluorouracil and Oxaliplatin, 5-fluorouracil and irinotecan, or all three agents, or others. After 7 days of treatment, the tumor cells were stained with EdU, Hoechst and EpCAM with the Cell Quantitative Detection Kit. Images were acquired with an automated microscopic image-scanning system and analyzed with the built-in software.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer Metastatic
Keywords
Personalized, Drug Sensitivity Test, Chemotherapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stage III/IV gastrointestinal cancer patients
Arm Type
Experimental
Arm Description
The study group (Personalized drug sensitivity test) was treated according to the physician's opinion. Tumor tissues are obtained during the surgery or via biopsy with informed consent, for the purpose of ex vivo assay.
Intervention Type
Diagnostic Test
Intervention Name(s)
Personalized drug sensitivity test
Intervention Description
The patients underwent surgery to remove tumor and took out tumor specimens for research. The tumor cells were expanded ex vivo drug sensitivity assay.
The drugs used in the study were 5-fluorouracil, Oxaliplatin, and irinotecan at C0 = 10 mM, 2.5 mM and 0.02 mM, respectively. They were applied either as single agents or in combinations of 5-fluorouracil and Oxaliplatin, 5-fluorouracil and irinotecan, or all three agents, or others. After 7 days of treatment, the tumor cells were stained with EdU, Hoechst and EpCAM with the Cell Quantitative Detection Kit. Images were acquired with an automated microscopic image-scanning system and analyzed with the built-in software.
Primary Outcome Measure Information:
Title
ex vivo Maximal Inhibition Index (MI)
Description
The effectiveness of each therapeutic regimen was evaluated and quantified using the formula: Maximum Inhibition (MI)=N0/Nd, where N0 and Nd denotes the number of EpCAM+ EdU+ epithelial cells in the wells of control or withthe drug at concentration C0, respectively.
Time Frame
1 month after the tissue acquisition
Secondary Outcome Measure Information:
Title
Disease Control Rate(DCR)after chemotherapy
Description
Disease Control Rate(DCR)after chemotherapy.
Time Frame
3 months after chemotherapy
Title
Progression free survival (PFS) after chemotherapy
Description
Progression free survival (PFS) after chemotherapy
Time Frame
1 year after chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients between 18 and 70 years old, male or female;
Voluntary patient consent;
Treatment-naïve, stage III/IV gastrointestinal cancer patients with pathology confirmation;
According clinical researcher, patient has operable tumor lesion, and tumor tissue can be obtained through surgical removal;
Good tolerability to standard chemotherapy regimen;
ECOG status <3;
Estimated survival time no less than 6 months;
Patient has at least one measurable disease lesion (according to RECIST1.1).
Exclusion Criteria:
Patient has received any prior anti-cancer treatment;
Participated in any other clinical study within 6 months;
Women currently breast feeding or pregnant;
Severe liver or kidney function impairment (Live function: TBIL ≤1.5×ULN,ALT & AST≤2.5×ULN);
Patients with liver metastasis ≤5.0×ULN;Kidney function:Cr ≤1.5×ULN and creatinine clearance rate≥ 50 mL/min (according to the Cockcroft-Gault formula);
Patients with cognitive impairment, psychological disease, or poor compliance;
Allergic to known chemotherapy ingredients;
Other factors researchers deemed not suitable for study participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingjie Li, M.D.
Phone
+86 13520186618
Email
liyingjiedr@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiwen Wu, M.D.
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingjie Li, M.D.
Phone
+86 135 2018 6618
Email
liyingjiedr@sina.com
First Name & Middle Initial & Last Name & Degree
Aiwen Wu, M.D.
First Name & Middle Initial & Last Name & Degree
Yingjie Li, M.D.
12. IPD Sharing Statement
Learn more about this trial
Drug Sensitivity Screening for Gastrointestinal Cancer
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