Drug Sensitivity Screening for Gastrointestinal Cancer

NCT04298489 | Unknown

• 1 other identifier: PKUCH-M01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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:

1. 1.Compare the ex vivo Maximal Inhibition Index(MI) and Drug Sensitivity Index (DSI) with patient's Overall Response Rate (ORR)
2. 2.Provide research support for future clinical treatment.

Conditions

Gastrointestinal Cancer Metastatic

Keywords

Personalized; Drug Sensitivity Test; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after the tissue acquisition

Secondary Outcomes (2)

• Disease Control Rate（DCR）after chemotherapy

  3 months after chemotherapy

• Progression free survival (PFS) after chemotherapy

  1 year after chemotherapy

Study Arms (1)

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.

Diagnostic Test: Personalized drug sensitivity test

Interventions

Personalized drug sensitivity test DIAGNOSTIC_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.

stage III/IV gastrointestinal cancer patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Study Officials

• Aiwen Wu, M.D.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingjie Li, M.D.

CONTACT

+86 13520186618; liyingjiedr@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: March 6, 2020
• Study Start: May 1, 2017
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

CN (1)