Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05203549
Other study ID # D1med-GC1001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date June 30, 2023

Study information

Verified date January 2022
Source D1 Medical Technology (Shanghai) Co., Ltd, China
Contact Hanqing Lin, PhD
Phone +8615921348040
Email linhq@d1med.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 the enrolled patients including medical history, physical examination records and clinical examination records will be collected. Tumor material of those patients will be obtained from gastric endoscopic biopsies or surgical resection. Patient-derived organoids (PDOs) will be established and cultured from gastric cancer tumor specimens. PDOs will then be treated with drugs of the chemotherapeutic regimens for gastric cancer. Organoid size and growth will be monitored before and after the treatment, and dose-response curves will be generated. As for the assessment of clinical outcomes of patients, tumor regression grade (TRG) systems will be used to evaluate tumor histological responses, and treatment responses will also be assessed by biomedical imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1). Consistency between treatment responses in PDO models and clinical outcomes of patients will be assessed by correlation analysis.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date June 30, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Age from 18 to 70 years old, no gender limit 2. 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 3. 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 4. Stage IVb or locally unresectable late-stage gastric or GEJ cancer, previously never received chemotherapy 5. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1 6. 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 7. Fresh tumor tissue biopsies are obtainable and the clinical information of the patients is complete 8. Patients have been informed and consented Exclusion Criteria: 1. Previously received neoadjuvant therapy 2. Previously had other types of malignancy and received chemotherapy or radiotherapy 3. Previously had chicken pox, herpes zoster or other severe contagious diseases 4. Have severe active ulcer (gastrointestinal tract, skin, etc.) or have developed a high fever 5. Have a medical history of myocardial infarction, cerebral infarction, or pulmonary embolism 6. Have complications of gastric cancer (bleeding, perforation and obstruction etc.) and need emergency operation 7. Pregnant or lactating women 8. Have severe mental diseases 9. Allergic to chemotherapy drugs 10. Have metastatic brain cancer 11. Refuse to cooperate and to complete a treatment

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Zhongshan Hospital Fudan University Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
D1 Medical Technology (Shanghai) Co., Ltd, China Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Correlation between results of the drug sensitivity tests in patient-derived organoid models and clinical outcomes The results from drug sensitivity tests in patient-derived organoid models will be compared with clinical outcomes after neoadjuvant therapy, conversion therapy and palliative therapy, followed by correlation analysis. 2021.05 - 2023.12
See also
  Status Clinical Trial Phase
Recruiting NCT05551416 - The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Recruiting NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT05536102 - The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Active, not recruiting NCT04082364 - Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer Phase 2/Phase 3
Withdrawn NCT03766607 - Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT01924533 - Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. Phase 3
Terminated NCT01641939 - A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Recruiting NCT04908813 - Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer Phase 2
Active, not recruiting NCT04249739 - Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive Phase 2
Recruiting NCT05514158 - To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) Phase 1
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2