Consistency Between Treatment Responses in PDO Models and Clinical Outcomes in Gastric Cancer

NCT05203549 | Unknown

• 1 other identifier: D1med-GC1001
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2021.05 - 2023.12

Secondary Outcomes (1)

• Correlation between results of the drug sensitivity tests in patient-derived organoid models and clinical outcomes

  2021.05 - 2023.12

Study Arms (1)

Gastric cancer patients

Patients with gastric cancer will undergo tumor biopsy before receiving neoadjuvant therapy, conversion therapy, or palliative therapy

Procedure: Tumor biopsy

Interventions

Tumor biopsy PROCEDURE

Patients with gastric cancer will undergo tumor biopsy before receiving neoadjuvant therapy, conversion therapy, or palliative therapy

Gastric cancer patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• D1 Medical Technology (Shanghai) Co., Ltd, China: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A part of the tumor will be removed from the primary tumor.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Xuefei Wang, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanqing Lin, PhD

CONTACT

+8615921348040; linhq@d1med.com

Zhaoqing Tang, MD

CONTACT

+8613817125778; tang.zhaoqing@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: May 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: June 30, 2023
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)