Clinical trial NCT05351398: The Clinical Efficacy of Drug Sensitive Neoadjuvant Chemotherapy Based on Organoid Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer
Official title: The Clinical Efficacy of Patient-derived Organoid-based Drug Sensitive Neoadjuvant Chemotherapy Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer: a Prospective Multi-center Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Gastric Carcinoma
Keywords: advanced gastric carcinoma
patient-derived organoid
personalized treatment
Neoadjuvant Chemotherapy
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai OneTar Biomedicine Co., Ltd.
First posted: 2022-04-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced gastric cancer whose tumor is located in the stomach and need neoadjuvant therapy before radical surgery.

Brief summary: Neoadjuvant chemotherapy has become the mainstream recommended treatment for advanced gastric cancer. However, due to the heterogeneity of gastric cancer, part of some patients fail to benefit from the treatment. This project aims to compare the clinical efficacy of individualized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay and traditional regimen, exploring the advantages and disadvantages of these two treatments. And access the safety and clinical value of the personalized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay in advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* A biopsy proven histological diagnosis of gastric adenocarcinoma or high-grade intraepithelial neoplasia
* Tumor located at stomach
* Chest/abdomen/pelvis CT scans or gastric cancer staging CT scan evaluate the clinical stage of tumor as stage III:

A. preoperative staging cT3-4N1-2 B. excluding distant organ metastasis (M0)

* Eastern Cooperative Oncology Group (ECOG) score ≤1
* Willing to participate and informed consent signed

Exclusion Criteria:

* Pregnant or lactating women
* Synchronous or heterochronic malignant carcinomas
* History of malignant carcinomas
* Clinical evidence of metastasis
* Abnormal heart, lung, liver, kidney, hematopoietic function and bone marrow reserve function, unable to tolerate surgical treatment and chemotherapy
* Mental illness or other serious cardiovascular disease
* Emergency procedure

Primary outcomes:
measure: Objective Response Rate
timeFrame: an average of 1 year
Secondary outcomes:
measure: postoperative complication
timeFrame: an average of 1 year
measure: postoperative tumor regression grading
timeFrame: an average of 1 year
measure: 3-year recurrence rate
timeFrame: an average of 3 year
measure: chemotherapy tolerance and adverse reaction rate
timeFrame: an average of 1 year
measure: R0 resection rate
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospttal
state: Sahnghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jing Sun, PhD
role: PRINCIPAL_INVESTIGATOR
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