Gastric CancerNCT05203549
Consistency Between Treatment Responses in PDO Models and Clinical Outcomes in Gastric Cancer
An observational study of Gastric Cancer, run by D1 Medical Technology (Shanghai) Co., Ltd, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Tumor biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Pregnant or lactating women
- Have severe mental diseases
- Allergic to chemotherapy drugs
- Have metastatic brain cancer
- Refuse to cooperate and to complete a treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Xuefei Wang, MD, +8613917270528, wang.xuefei@zs-hospital.sh.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- Tumor biopsy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biopsyProcedure or surgery
Patients with gastric cancer will undergo tumor biopsy before receiving neoadjuvant therapy, conversion therapy, or palliative therapy
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer patients | Patients with gastric cancer will undergo tumor biopsy before receiving neoadjuvant therapy, conversion therapy, or palliative therapy Receives: Procedure: Tumor biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of patient-derived organoids
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.
Measured: 2021.05 - 2023.12
Secondary outcomes (1)
Correlation between results of the drug sensitivity tests in patient-derived organoid models and clinical outcomes
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.
Measured: 2021.05 - 2023.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 May 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D1 Medical Technology (Shanghai) Co., Ltd, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
- Investigators
- Xuefei Wang, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203549
- Sponsor's protocol ID
- D1med-GC1001
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency Between Treatment Responses in Patient-Derived Organoid (PDO) Models and Clinical Outcomes of Neoadjuvant Therapy, Conversion Therapy and Palliative Therapy in Gastric Cancer
- ClinicalTrials.gov ID
- NCT05203549
- Acronym / sponsor ID
- D1med-GC1001
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- D1 Medical Technology (Shanghai) Co., Ltd, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer patients | – | Procedure: Tumor biopsyPatients with gastric cancer will undergo tumor biopsy before receiving neoadjuvant therapy, conversion therapy, or palliative therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor biopsyPatients with gastric cancer will undergo tumor biopsy before receiving neoadjuvant therapy, conversion therapy, or palliative therapy | Procedure or surgery | Gastric cancer patients |
Primary outcome
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.
1 secondary outcome
Correlation between results of the drug sensitivity tests in patient-derived organoid models and clinical outcomes
Time frame: 2021.05 - 2023.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuefei Wang, MD principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by D1 Medical Technology (Shanghai) Co., Ltd, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanqing Lin, PhD (+8615921348040, linhq@d1med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of patient-derived organoids (time frame: 2021.05 - 2023.12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.