Precise Prediction of Therapy EfficiencyNCT05616533
Evaluation of Consistency of PDX Model for Predicting Therapeutic Effect of Gastric Cancer
An observational study of Precise Prediction of Therapy Efficiency, run by Zhejiang University at 1 site in China.
Trial summary
The goal of this study is to compare the tumor response in gastric cancer patients given neoadjuvant chemotherapy with the corresponding result obtained from zebrafish patient-derived tumor xenograft(PDX) model given the same regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Precise Prediction of Therapy Efficiency
- What is being tested?
- biopsy of tumor before treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2023to 30 Jun 2025
- How long will I take part?
- 6 Months
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with advanced gastric cancer that will be treated with neoadjuvant chemotherapy, and surgery will be performed after 2 or 3 cycle of neoadjuvant therapy.
Who may be able to join
- patients aged 18-75years,
- patients with gastric cancer confirmed by histology or cytology at first visit,
- patients with advanced tumor by imaging evaluation,
- patients with preoperative neoadjuvant therapy;
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1;
- tolerance to chemotherapy in laboratory examination;
- hematology examination: no obvious signs of hematological diseases, ANC ≥1.5 × 109/L before enrollment; Platelet count ≥80 × 109/L, HB ≥90 g/L, WBC ≥3.0 × 109/L, and no bleeding tendency;
- biochemical examination: Total Bilirubin <1.5 times of upper limit of normal value, AST, ALT < 2.5 times of upper limit of normal value, creatinine < 1.5 times of upper limit of normal value;
Who cannot join
- patients with inoperable advanced gastric cancer,
- patients with metastatic or primary gastric cancer,
- pregnant or lactating women,
- patients with a history of other malignancies in the last 5 years;
- for those with a history of uncontrolled epilepsy, central nervous system disease or mental disorders, the severity of the clinical condition was assessed by the investigator as impeding the signing of informed consent or affecting the patient's compliance with oral medication;
- clinically serious (i.e. active) heart disease, such as symptomatic coronary heart disease, NYHA Class II or more heart failure, or arrhythmias requiring medical intervention; Or a history of myocardial infarction within the last 12 months;
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- severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc.
- gastrointestinal obstruction or abnormal physiological function, or malabsorption syndrome, which may affect drug absorption;
- gastrointestinal bleeding in the last two weeks or at high risk of bleeding as judged by the investigator;
- patients with known peripheral nerve disease ≥ NCI-CTC AE Grade 1, but only with deep tendon reflexes (DTR) ;
- organ transplantation requires immunosuppressive therapy;
- the presence of any active, known or suspected autoimmune disease.
- uncontrolled severe infection or other severe concomitant disease
- hypersensitivity to paclitaxel, Oxaliplatin, 5-FU, or any clinically useful anti-gastric cancer agent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
gastrointestinal department of second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Xiaoli Jin, doctor, 86-13605809870, Jinxiaoli@zju.edu.cn
About this study
Official title: Consistency Evaluation of a Patient-derived Tumor Xenograft Zebrafish Model in Predicting Anti-cancer Efficacy of Conventional Drugs for Gastric Cancer
The goal of this study is to compare the tumor response in gastric cancer patients given neoadjuvant chemotherapy with the corresponding result obtained from zebrafish patient-derived tumor xenograft(PDX) model given the same regimen. The main question it aims to answer is whether this PDX model of zebrafish could accurately predict the effect of chemotherapy in advanced gastric cancer. Participants will be given the standard neoadjuvant treatment administrated by their own doctors and tumor response will be observed and recorded. Meanwhile, tumor samples derived from patients before chemotherapy will be transplanted to zebrafish and the same regimen will be given to the PDX models correspondingly. The tumor response data both from clinical practice and PDX model platform will be analysed and compared to evaluate the power of this zebrafish model platform in drug efficiency prediction.
Read the detailed description
The prognosis of advanced gastric cancer treated with surgery only remains quite disappointed. Adjuvant and neoadjuvant chemotherapy had been greatly raising the survive of advanced gastric cancer. However, how to acquired the tumor sensitivity to the following chemotherapy before the treatment, in order to admit reasonable drugs, avoid unexpected progression of tumor and unnecessary loss of surgical opportunity, remained the focus in this field. Zebrafish CDX/PDX model provides a reliable potential platform for drug sensitivity prediction, but the drug sensitivity result concluded by this platform could not fully represent its actual clinic efficacy in human body. Consistency of therapeutic efficacy could be concluded only by comparing the results both in the human body and the model that was given the same regimens. This is the golden standard to evaluate whether the PDX model of zebrafish could accurately predict the effect of chemotherapy, as well as the primary foundation of the clinical practice with this zebrafish model platform for drug efficiency prediction. Therefore, we intend to carry out this clinical study in gastric cancer patients whom were given neoadjuvant chemotherapy. Enrolled individuals was given a biopsy through endoscopy to obtain samples that would be transplanted to the zebrafish model. Same drugs would be give both for the patient and corresponding zebrafish model, and results would be observed carefully to assess the consistency between the model and the actual practice. This may give strong support for the future clinical use of the platform.
- Conditions
- Precise Prediction of Therapy Efficiency
- Being tested
- biopsy of tumor before treatment
- Keywords
- gastric cancer, zebrafish, patient-derived tumor xenograft(PDX) model, prediction, therapy efficiency
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy of tumor before treatmentOther
samples obtained from biopsy will be used in the zebrafish PDX model
| Study group | Role | What they receive |
|---|---|---|
| focused group | Advanced gastric patients that will be treated with neoadjuvant therapy are enrolled. Every clinical decision such as regimen or dosage will be decided by their own doctors without any interventions. Tumor samples will be obtained before the first cycle of the treatment and will be transplanted to the zebrafish model. Compared results will be analyzed in future. Receives: Other: biopsy of tumor before treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The coincidence rate of tumor response obtained from 50 PDX models with clinical real tumor response acquired from corresponding patients received neoadjuvant therapy.
Drugs used in the zebrafish PDX model are as same as those administrated in the clinical practice with the corresponding patient. Immunofluorescence quantitative detection would be used to evaluate the tumor response in PDX model while RECIST 1.1 and Becker criterion would be applied to evaluate the real tumor response in clinical practice.
Measured: about 3 months (from the first cycle of neoadjuvant therapy to the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start12 Sep 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precise Prediction of Therapy EfficiencyStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Hunter Biotechnology Incorporation
- Responsible party
- Principal investigator, Xiaoli JIn, Zhejiang University
- Investigators
- Xiaoli Jin, Dr, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616533
- Sponsor's protocol ID
- ZRWC_GC_R001
- Status last verified
- Dec 2023
- First submitted
- 7 Nov 2022
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency Evaluation of a Patient-derived Tumor Xenograft Zebrafish Model in Predicting Anti-cancer Efficacy of Conventional Drugs for Gastric Cancer
- ClinicalTrials.gov ID
- NCT05616533
- Acronym / sponsor ID
- ZRWC_GC_R001
- Conditions
- Precise Prediction of Therapy Efficiency
- Keywords
- gastric cancer, zebrafish, patient-derived tumor xenograft(PDX) model, prediction, therapy efficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Hunter Biotechnology Incorporation
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Nov 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.
The goal of this study is to compare the tumor response in gastric cancer patients given neoadjuvant chemotherapy with the corresponding result obtained from zebrafish patient-derived tumor xenograft(PDX) model given the same regimen. The main question it aims to answer is whether this PDX model of zebrafish could accurately predict the effect of chemotherapy in advanced gastric cancer. Participants will be given the standard neoadjuvant treatment administrated by their own doctors and tumor response will be observed and recorded. Meanwhile, tumor samples derived from patients before chemotherapy will be transplanted to zebrafish and the same regimen will be given to the PDX models correspondingly. The tumor response data both from clinical practice and PDX model platform will be analysed and compared to evaluate the power of this zebrafish model platform in drug efficiency prediction.
Detailed description
The prognosis of advanced gastric cancer treated with surgery only remains quite disappointed. Adjuvant and neoadjuvant chemotherapy had been greatly raising the survive of advanced gastric cancer. However, how to acquired the tumor sensitivity to the following chemotherapy before the treatment, in order to admit reasonable drugs, avoid unexpected progression of tumor and unnecessary loss of surgical opportunity, remained the focus in this field. Zebrafish CDX/PDX model provides a reliable potential platform for drug sensitivity prediction, but the drug sensitivity result concluded by this platform could not fully represent its actual clinic efficacy in human body. Consistency of therapeutic efficacy could be concluded only by comparing the results both in the human body and the model that was given the same regimens. This is the golden standard to evaluate whether the PDX model of zebrafish could accurately predict the effect of chemotherapy, as well as the primary foundation of the clinical practice with this zebrafish model platform for drug efficiency prediction. Therefore, we intend to carry out this clinical study in gastric cancer patients whom were given neoadjuvant chemotherapy. Enrolled individuals was given a biopsy through endoscopy to obtain samples that would be transplanted to the zebrafish model. Same drugs would be give both for the patient and corresponding zebrafish model, and results would be observed carefully to assess the consistency between the model and the actual practice. This may give strong support for the future clinical use of the platform.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| focused group | – | Other: biopsy of tumor before treatmentAdvanced gastric patients that will be treated with neoadjuvant therapy are enrolled. Every clinical decision such as regimen or dosage will be decided by their own doctors without any interventions. Tumor samples will be obtained before the first cycle of the treatment and will be transplanted to the zebrafish model. Compared results will be analyzed in future. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with advanced gastric cancer that will be treated with neoadjuvant chemotherapy, and surgery will be performed after 2 or 3 cycle of neoadjuvant therapy.
Key inclusion criteria (8 listed)
- patients aged 18-75years,
- patients with gastric cancer confirmed by histology or cytology at first visit,
- patients with advanced tumor by imaging evaluation,
- patients with preoperative neoadjuvant therapy;
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1;
Key exclusion criteria (14 listed)
- patients with inoperable advanced gastric cancer,
- patients with metastatic or primary gastric cancer,
- pregnant or lactating women,
- patients with a history of other malignancies in the last 5 years;
- for those with a history of uncontrolled epilepsy, central nervous system disease or mental disorders, the severity of the clinical condition was assessed by the investigator as impeding the signing of informed consent or affecting the patient's compliance with oral medication;
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 |
|---|---|---|
| biopsy of tumor before treatmentsamples obtained from biopsy will be used in the zebrafish PDX model | Other | focused group |
Primary outcome
The coincidence rate of tumor response obtained from 50 PDX models with clinical real tumor response acquired from corresponding patients received neoadjuvant therapy.
Time frame: about 3 months (from the first cycle of neoadjuvant therapy to the surgery)
Drugs used in the zebrafish PDX model are as same as those administrated in the clinical practice with the corresponding patient. Immunofluorescence quantitative detection would be used to evaluate the tumor response in PDX model while RECIST 1.1 and Becker criterion would be applied to evaluate the real tumor response in clinical practice.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
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.
Xiaoli Jin, Dr principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Precise Prediction of Therapy Efficiency, run by Zhejiang University 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 14 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 26 Dec 2023. 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 Xiaoli Jin, Dr (86-13605809870, Jinxiaoli@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The coincidence rate of tumor response obtained from 50 PDX models with clinical real tumor response acquired from corresponding patients received neoadjuvant therapy. (time frame: about 3 months (from the first cycle of neoadjuvant therapy to the surgery)). 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 26 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.