Status:
UNKNOWN
Consistency Between Treatment Responses in PDO Models and Clinical Outcomes in Gastric Cancer
Lead Sponsor:
D1 Medical Technology (Shanghai) Co., Ltd, China
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Brief 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 prolongi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05203549
Start Date
May 1 2021
End Date
June 30 2023
Last Update
January 24 2022
Active Locations (1)
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1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032