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The goal of this study is to evaluate the consistency between in vitro tumor organoid drug sensitivity and the therapeutic efficacy of in vivo drug treatment.
Participants are required to provide one of fresh tumor tissues (including ascites, pleural effusion, biopsy tissues, palliative surgery specimens, etc.) for the purpose of culturing tumor organoids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Organoid generation | Experimental | All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy of tumor tissue for organoid culture | Procedure | By collecting fresh tumor tissues (including ascites, pleural effusion, biopsy tissues, palliative surgery specimens, etc.) and culturing them into organoids in vitro, this study conducts drug sensitivity tests on various clinically approved drugs. The most sensitive drug for the patient is selected for treatment, and the study aims to evaluate the clinical effectiveness of the drug and its consistency with in vitro organoid drug sensitivity. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS (Progressive free survival) | The time from initiation of treatment to the occurrence of disease progression or death. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| DCR (Disease control rate) | The percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention. | 6 months |
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Inclusion Criteria:
Age ≥ 18 and ≤ 75 years old.
Metastatic pancreatic cancer with progression after second-line or higher treatment, metastatic gastric cancer with progression after third-line or higher treatment, or metastatic pancreatic or gastric cancer patients who cannot tolerate standard treatment regimens.
Able to provide fresh tumor tissue specimens for organoid culture, including: ascites, pleural effusion, tumor biopsy tissues, tumor surgical specimens, etc.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
Adequate organ function, including the following:
At least one measurable or evaluable lesion.
For women: Must be sterilized, postmenopausal, or using highly effective contraception during treatment and for 3 months after treatment; must not be pregnant or breastfeeding during treatment.
Patient compliance and geographic proximity to ensure adequate follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Liu, MD | Contact | +86-571-87235409 | liuzhen@cancer.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |