Drug Sensitivity Screening for Gastrointestinal Cancer

  • STATUS
    Recruiting
  • End date
    Apr 30, 2022
  • participants needed
    40
  • sponsor
    Beijing Cancer Hospital
Updated on 24 January 2021

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:

  1. Compare the ex vivo Maximal Inhibition Index(MI) and Drug Sensitivity Index (DSI) with patient's Overall Response Rate (ORR)
  2. 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.

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.

Details
Condition Gastrointestinal Cancer Metastatic
Treatment Personalized drug sensitivity test
Clinical Study IdentifierNCT04298489
SponsorBeijing Cancer Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Gastrointestinal Cancer Metastatic?
Do you have any of these conditions: Do you have Gastrointestinal Cancer Metastatic??
Adult patients between 18 and 70 years old, male or female
Voluntary patient consent
Treatment-nave, 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 1.5ULNALT & AST2.5ULN)
Patients with liver metastasis 5.0ULNKidney functionCr 1.5ULN 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
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