Gastric Cancer Clinical Trial
Official title:
Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer
Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response for resectable gastric cancer
1. Background: According to Global Cancer Statistics of International Agency for Research on Cancer under World Health Organization, stomach cancer is the fifth most common cancer as there were over 1 million new cases in 2018 and the third leading cause of cancer death by 783,000 people are estimated to die of stomach cancer. In Korea, gastric cancer is the most frequent cancer in 13.3% of all cancer cases by the report of Korea Central Cancer Registry in 2018. Since 2010, adjuvant chemotherapy with advanced gastric cancer stage 2 and stage 3 patients following gastrectomy has become a standard treatment through clinical validation of increasing the patient's survival rate. However, even in the second and third stages of the same stomach cancer, the biological properties may be different. 2. Purpose: The nProfiler® 1 Stomach Cancer Assay is a molecular diagnostic test to predict the prognosis for patients with stage Ⅱ-Ⅲ advanced gastric cancer. This study will evaluate the clinical utility of nProfiler® 1 Stomach Cancer Assay by recruiting subjects from multi centers and observing the 5-year survival rates of Low risk, Intermediate risk, High risk according to gastric cancer prognostic molecular diagnostic test. 3. Study Procedure: - Obtaining of informed consent form - Review of provider's eligibility/ Sample preparation and delivery - Sample criteria evaluation - Subject enrollment - Gastric cancer prognostic prediction molecular diagnostic test - Prognostic group result report - 5-yr survival follow-up - Statistical analysis 4. Outcome Measures: The following efficacy outcome measures will be assessed: - Primary efficacy outcome measure :High risk and low risk group's 5-yr Overall Survival(OS) rate - Secondary efficacy outcome measure - High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate - Intermediate risk group's 5-yr OS and 3-yr DFS rate - Subgroup analysis : Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr DFS rate) ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05551416 -
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
|
||
| Completed |
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 | |
| Active, not 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 |