- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05203549
Consistency Between Treatment Responses in PDO Models and Clinical Outcomes in Gastric Cancer
January 10, 2022 updated by: D1 Medical Technology (Shanghai) Co., Ltd, China
Consistency Between Treatment Responses in Patient-Derived Organoid (PDO) Models and Clinical Outcomes of Neoadjuvant Therapy, Conversion Therapy and Palliative Therapy in Gastric Cancer
Gastric cancer is the fourth leading cause of cancer-related death worldwide.
Accurate assessment of the clinical responses to current treatment regimens is key to improving the prognosis and prolonging the survival of patients.
In this study, two hundred and fifty patients with gastric cancer who ought to receive neoadjuvant therapy, conversion therapy or palliative chemotherapy will be enrolled, and patient-derived organoids from their tumor biopsies will be used to test the sensitivity of chemotherapy drugs which mainly include 5-fluorouracil, irinotecan, oxaliplatin and paclitaxel.
Study Overview
Detailed Description
Two hundred and fifty stage II-IV gastric cancer patients who should receive neoadjuvant therapy, conversion therapy or palliative chemotherapy will be enrolled in this study.
Baseline information of the enrolled patients including medical history, physical examination records and clinical examination records will be collected.
Tumor material of those patients will be obtained from gastric endoscopic biopsies or surgical resection.
Patient-derived organoids (PDOs) will be established and cultured from gastric cancer tumor specimens.
PDOs will then be treated with drugs of the chemotherapeutic regimens for gastric cancer.
Organoid size and growth will be monitored before and after the treatment, and dose-response curves will be generated.
As for the assessment of clinical outcomes of patients, tumor regression grade (TRG) systems will be used to evaluate tumor histological responses, and treatment responses will also be assessed by biomedical imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1).
Consistency between treatment responses in PDO models and clinical outcomes of patients will be assessed by correlation analysis.
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hanqing Lin, PhD
- Phone Number: +8615921348040
- Email: linhq@d1med.com
Study Contact Backup
- Name: Zhaoqing Tang, MD
- Phone Number: +8613817125778
- Email: tang.zhaoqing@zs-hospital.sh.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Zhongshan Hospital Fudan University
-
Contact:
- Xuefei Wang, MD
- Phone Number: +8613917270528
- Email: wang.xuefei@zs-hospital.sh.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Two hundred and fifty patients with gastric cancer who need to receive neoadjuvant therapy, conversion therapy or palliative chemotherapy are included in this study.
Description
Inclusion Criteria:
- Age from 18 to 70 years old, no gender limit
- The primary tumor is diagnosed as gastric adenocarcinoma (papillary, tubular, signet ring cell, poorly differentiated and mucinous adenocarcinoma) by endoscopic biopsy sampling and follow-up histopathological staining
- The pre-operative staging includes: a) Stage IVa(cT4bNanyM0),resectable; b) Stage II-III(cT1-2N1-3M0、cT3-4aN0-3M0), gastro-oesophageal junction (GEJ) cancer;c) Stage III(cT3-4aN1-3M0), non-GEJ cancer, appropriate for neoadjuvant therapy
- Stage IVb or locally unresectable late-stage gastric or GEJ cancer, previously never received chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
- The function of major organs is normal, meeting the following criteria: a) routine blood tests (no blood transfusion in the past 14 days): HB≥90g/L;ANC ≥1.5×109/L;PLT ≥80×109/L;b)blood biochemical parameters: BIL <1.5-fold upper limit of normal (ULN);ALT<2.5×ULN; AST<2.5×ULN;Crea≤1×ULN
- Fresh tumor tissue biopsies are obtainable and the clinical information of the patients is complete
- Patients have been informed and consented
Exclusion Criteria:
- Previously received neoadjuvant therapy
- Previously had other types of malignancy and received chemotherapy or radiotherapy
- Previously had chicken pox, herpes zoster or other severe contagious diseases
- Have severe active ulcer (gastrointestinal tract, skin, etc.) or have developed a high fever
- Have a medical history of myocardial infarction, cerebral infarction, or pulmonary embolism
- Have complications of gastric cancer (bleeding, perforation and obstruction etc.) and need emergency operation
- Pregnant or lactating women
- Have severe mental diseases
- Allergic to chemotherapy drugs
- Have metastatic brain cancer
- Refuse to cooperate and to complete a treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gastric cancer patients
Patients with gastric cancer will undergo tumor biopsy before receiving neoadjuvant therapy, conversion therapy, or palliative therapy
|
Patients with gastric cancer will undergo tumor biopsy before receiving neoadjuvant therapy, conversion therapy, or palliative therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establishment of patient-derived organoids
Time Frame: 2021.05 - 2023.12
|
Patient-derived organoids (PDOs) will be established from gastric cancer tumor specimens and the rate of successful generation of gastric cancer organoids will be calculated.
|
2021.05 - 2023.12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between results of the drug sensitivity tests in patient-derived organoid models and clinical outcomes
Time Frame: 2021.05 - 2023.12
|
The results from drug sensitivity tests in patient-derived organoid models will be compared with clinical outcomes after neoadjuvant therapy, conversion therapy and palliative therapy, followed by correlation analysis.
|
2021.05 - 2023.12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Xuefei Wang, MD, Shanghai Zhongshan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Anticipated)
January 31, 2023
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
January 10, 2022
First Posted (Actual)
January 24, 2022
Study Record Updates
Last Update Posted (Actual)
January 24, 2022
Last Update Submitted That Met QC Criteria
January 10, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1med-GC1001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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