Clinical trial · Interventional
Drug Sensitivity Screening for Gastrointestinal Cancer
Personalized Drug Sensitivity Test for Late Stage, Potentially Operable Gastrointestinal Cancer Using Patient Derived Primary Cell Culture
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized drug sensitivity test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- stage III/IV gastrointestinal cancer patients
- 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.
- interventionNames
- Diagnostic Test: Personalized drug sensitivity test
Primary outcomes (1)
- measure
- ex vivo Maximal Inhibition Index (MI)
- timeFrame
- 1 month after the tissue acquisition
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients between 18 and 70 years old, male or female; 2. Voluntary patient consent; 3. Treatment-naïve, stage III/IV gastrointestinal cancer patients with pathology confirmation; 4. According clinical researcher, patient has operable tumor lesion, and tumor tissue can be obtained through surgical removal; 5. Good tolerability to standard chemotherapy regimen; 6. ECOG status \<3; 7. Estimated survival time no less than 6 months; 8. Patient has at least one measurable disease lesion (according to RECIST1.1). Exclusion Criteria: 1. Patient has received any prior anti-cancer treatment; 2. Participated in any other clinical study within 6 months; 3. Women currently breast feeding or pregnant; 4. Severe liver or kidney function impairment (Live function: TBIL ≤1.5×ULN,ALT \& AST≤2.5×ULN); 5. 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); 6. Patients with cognitive impairment, psychological disease, or poor compliance; 7. Allergic to known chemotherapy ingredients; 8. Other factors researchers deemed not suitable for study participation.
References
Publications (0)
Data not yet available