Status:
UNKNOWN
Drug Sensitivity Screening for Gastrointestinal Cancer
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Gastrointestinal Cancer Metastatic
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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 earl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04298489
Start Date
May 1 2017
End Date
April 30 2022
Last Update
March 6 2020
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142