Gastrointestinal Cancer MetastaticNCT04298489
Drug Sensitivity Screening for Gastrointestinal Cancer
A study testing Personalized drug sensitivity test in people with Gastrointestinal Cancer Metastatic, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Cancer Metastatic
- What is being tested?
- Personalized drug sensitivity test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yingjie Li, M.D., +86 135 2018 6618, liyingjiedr@sina.com
Aiwen Wu, M.D.
About this study
Official title: 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.
Study objectives: Personalized drug sensitivity test for late stage,potentially operable gastrointestinal cancer using patient derived primary cell culture.
Read more
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.
Read the 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.
- Conditions
- Gastrointestinal Cancer Metastatic
- Being tested
- Personalized drug sensitivity test
- Keywords
- Personalized, Drug Sensitivity Test, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized drug sensitivity testDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| stage III/IV gastrointestinal cancer patients | Experimental | 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. Receives: Diagnostic Test: Personalized drug sensitivity test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after the tissue acquisition
Secondary outcomes (2)
Disease Control Rate（DCR）after chemotherapy
Disease Control Rate（DCR）after chemotherapy.
Measured: 3 months after chemotherapy
Progression free survival (PFS) after chemotherapy
Progression free survival (PFS) after chemotherapy
Measured: 1 year after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 May 2017
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiwen Wu, Peking University Cancer Hospital & Institute
- Investigators
- Aiwen Wu, M.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298489
- Sponsor's protocol ID
- PKUCH-M01
- Status last verified
- Mar 2020
- First submitted
- 10 Dec 2018
- Last updated
- 6 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Drug Sensitivity Test for Late Stage, Potentially Operable Gastrointestinal Cancer Using Patient Derived Primary Cell Culture
- ClinicalTrials.gov ID
- NCT04298489
- Acronym / sponsor ID
- PKUCH-M01
- Conditions
- Gastrointestinal Cancer Metastatic
- Keywords
- Personalized, Drug Sensitivity Test, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stage III/IV gastrointestinal cancer patients | Experimental | Diagnostic Test: Personalized drug sensitivity testThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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；
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized drug sensitivity testThe 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. | Diagnostic test | stage III/IV gastrointestinal cancer patients |
Primary outcome
ex vivo Maximal Inhibition Index (MI)
Time frame: 1 month after the tissue acquisition
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.
2 secondary outcomes
Disease Control Rate（DCR）after chemotherapy
Time frame: 3 months after chemotherapy
Progression free survival (PFS) after chemotherapy
Time frame: 1 year after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiwen Wu, M.D. principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized drug sensitivity test in people with Gastrointestinal Cancer Metastatic, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingjie Li, M.D. (+86 13520186618, liyingjiedr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ex vivo Maximal Inhibition Index (MI) (time frame: 1 month after the tissue acquisition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.