Gastric Cancer Clinical Trial
— ANZ UGIOfficial title:
The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions
Status | Recruiting |
Enrollment | 500 |
Est. completion date | September 14, 2028 |
Est. primary completion date | March 14, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - UGI neoplastic lesions > 10mm - Lesions for ESD limited to the mucosal and/or submucosal layer OR - Lesions for EFTR limited to the muscularis propria layer OR - Lesions for STER limited to the submucosal and/or muscularis propria layer - Aged 18 years or older Exclusion Criteria: - Age less than 18 - Unable to give informed consent - Pregnant or lactating patients - Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally |
Country | Name | City | State |
---|---|---|---|
Australia | Westmead Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Western Sydney Local Health District |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection | Determined based on clear margins in histology review | 2 weeks | |
Primary | Safety: intra and post procedural; bleeding; perforation; anaesthetic | Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome | 30 day | |
Primary | Long term outcomes: recurrent and residual disease | Determined at subsequent procedures | 3 years | |
Secondary | Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives | Determined after follow up procedure to confirm no recurrence | 6 months | |
Secondary | Need for more than one endoscopic therapy | Determined after follow up procedures | 3 years | |
Secondary | Need for surgery | Determined after follow up procedures, histological review | 2 months | |
Secondary | Post ESD, EFTR, STER defect features | Determined after complete resection | 1 day | |
Secondary | Patient interviews/questionnaires | Determined after follow up procedures | 3 years |
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 |