Stomach Neoplasms Clinical Trial
Official title:
Prospective Study With HIPEC-AS in Patients With Locally Advanced, Limited or Extensive Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include "cT4aNxM0, P0 or cTxNxM1, P1" patients with gastric or esophagogastric junction adenocarcinoma, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period. Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c. The primary purpose is to evaluate the 3-year overall survival rate.
Status | Not yet recruiting |
Enrollment | 157 |
Est. completion date | October 2026 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. 18 years old = age = 75 years old; 2. The primary gastric lesion was diagnosed as gastric or esophagogastric junction adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and poorly differentiated adenocarcinoma. ) 3. The tumor is located in the stomach or esophagogastric junction (Siewert type II/III) 4. The preoperative clinical staging is cT4aNxM0, P0 or cTxNxM1*, P1 (*no other distant metastases except peritoneal metastasis) 5. Good bone marrow reserve function: HB=90g/L; ANC =1.5×10*9/L; PLT =80×10*9/L 6. Good liver and kidney function reserve: BIL = 1.5 times the upper limit of normal (ULN); ALT and AST = 2.5×ULN; Crea=1×ULN; 7. Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN, activated partial thromboplastin time (APTT) = 1.5 times ULN 8. ECOG (Eastern Cooperative Oncology Group) physical status score 0-2; 9. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc; 10. Written informed consent. Exclusion Criteria: 1. There are distant metastases other than peritoneal metastases; 2. Complications of gastric cancer require emergency treatment, such as bleeding, perforation, obstruction, etc.; 3. Suffer from other malignant tumors within five years; 4. Body temperature =38? or complicated with infectious diseases requiring systemic treatment; 5. If there is a history of uncontrolled epilepsy, central nervous system disease, or mental disorder, the investigator will determine whether the clinical severity hinders the signing of informed consent or affects the patient's compliance with oral medications; 6. Clinically serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention, or recent history of myocardial infarction within 12 months; 7. Severe respiratory diseases; 8. Severe liver and kidney dysfunction; 9. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome, which may affect the absorption of oral drugs; 10. Diseases such as severe diabetes, hyperthyroidism and hypothyroidism have not been clinically controlled. 11. Those who continue to use glucocorticoid therapy within 1 month (except for local application) or who require immunosuppressive therapy for organ transplantation; 12. Pregnant or lactating women; 13. The patient has participated or is participating in other clinical studies (within 6 months); |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xuefei.Wang |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year Overall Survival, OS | The time from the date of enrollment of the patient to the date of death or the date of the last follow-up | 3 years | |
Secondary | 3-year Progression Free Survival, PFS | The time from the date of enrollment of the patient to the first occurrence of disease progression or death from any cause. | 3 years | |
Secondary | NCI CTC Adverse Events Version 4.0 | Safety of HIPEC-AS plan | 1 year |
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 |