Stomach Neoplasms Clinical Trial
Official title:
The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites Due to Far Advanced Gastric Cancer
Verified date | January 2017 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a clinical Study to evaluate the effect, survival benefit and safety of intraperitoneal docetaxel combined with oral S-1 for advanced gastric cancer with malignant ascites.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Age 20-75years 2. Histologic confirmation of gastric adenocarcinoma 3. Positive peritoneal cytology or histological proven PM 4. Ascites in CT scan 5. Performance status (PS) = 2 on Eastern Cooperative Oncology Group (ECOG) scale 6. Adequate bone marrow and organ functions as defined below: Leucocyte=3,000/ul Absolute neutrophil counts =1,500/uL Platelet=100,000/uL Total bilirubin=1.5mg/dl ALT,AST= 2x ULN serum creatinine =1.5mg/dl 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 8. Provision of written informed consent Exclusion Criteria: 1. Presence of non-curable factors such as distant metastasis to liver or lung except of peritoneum 2. Other severe medical conditions such as symptomatic infectious disease,active hemorrhage/bleeding, or obstructive bowel disease 3. Life expectation = 3 months 4. With other malignant tumor 5. allergy to therapeutic drugs |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rate of ascites | From date of enrollment to three cycles of treatment,the ascites is evaluated by the Japanese conventional five-point method | 9 weeks | |
Secondary | one year survival rate | From date of enrollment until 1 year | 1 year | |
Secondary | side effects of chemotherapy | Grade refers to Common Terminology Criteria for Adverse Events(CTCAE)Version4.0 | 1 week to 18 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01950572 -
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
|
||
Recruiting |
NCT05161572 -
Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer
|
Phase 2 | |
Not yet recruiting |
NCT04351867 -
A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer
|
Phase 3 | |
Recruiting |
NCT02887612 -
ctDNA for Prediction of Relapse in Gastric Cancer
|
||
Active, not recruiting |
NCT02930291 -
The Effect of Preoperative Inflammation-based Scores on Postoperative Morbidity and Mortality for Laparoscopic Gastrectomy
|
||
Completed |
NCT02649348 -
Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome
|
N/A | |
Recruiting |
NCT02310230 -
An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy
|
N/A | |
Active, not recruiting |
NCT01609309 -
Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01)
|
Phase 3 | |
Completed |
NCT00375999 -
Docetaxel and Epirubicin in Advanced Gastric Cancer
|
Phase 2 | |
Completed |
NCT00382720 -
Docetaxel and Oxaliplatin in Gastric Cancer
|
Phase 2 | |
Completed |
NCT00980382 -
A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
Active, not recruiting |
NCT05602935 -
Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study
|
Phase 2 | |
Recruiting |
NCT05033392 -
PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer
|
Phase 2 | |
Completed |
NCT04539769 -
Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
|
Phase 2 | |
Active, not recruiting |
NCT02845986 -
Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02930278 -
The Effect of Preoperative Hemotologic Markers on Postoperative Long-term and Short-term Outcomes for Laparoscopic Gastrectomy
|
||
Completed |
NCT02902575 -
The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
|
N/A | |
Recruiting |
NCT04222114 -
Comparing the Efficacy and Safety of Intra-peritoneal Infusion of Catumaxomab and Treatment of Investigator Choice in Patients With Advanced Gastric Carcinoma With Peritoneal Metastasis
|
Phase 3 | |
Recruiting |
NCT05068180 -
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
|
Phase 4 |