Ignite Creation Date:
2024-05-06 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05095467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-10-27
First Post:
2021-10-25
Brief Title:
HIPEC-AS in Patients With Peritoneal Metastasis of the Stomach or Esophagogastric Junction
Sponsor:
XuefeiWang
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Prospective Study With HIPEC-AS in Patients With Locally Advanced Limited or Extensive Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
HIPEC-AS01 is an open prospective single-center phase II clinical study which will include Patients With cT4aNxM0 P0 or cTxNxM1 P1 Adenocarcinoma of the Stomach or Esophagogastric Junction 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
Intervention
Group A 1 cycle HIPECS-1 chemotherapy sequential 3 cycles of chemotherapy AS plan Q21d 3 surgeryHIPEC sequential 3 cycles of chemotherapy AS plan Q21d 3
Group B 1 cycle HIPECS-1 chemotherapy sequential 3 cycles of chemotherapy AS plan Q21d 3 surgeryHIPEC sequential 3 cycles of chemotherapy AS plan Q21d 3
Group C 1 cycle HIPECS-1 chemotherapy sequential 3 cycles of chemotherapy AS plan Q21d 3 HIPECS-1 chemotherapy sequential 3 cycles of chemotherapy AS plan Q21d 3
In this study the patients overall survival was the main evaluation index It is estimated that the case recruitment will be completed in 2 years and the follow-up time will be 3 years The total sample size is approximately 157 cases
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
Intervention
Group A 1 cycle HIPECS-1 chemotherapy sequential 3 cycles of chemotherapy AS plan Q21d 3 surgeryHIPEC sequential 3 cycles of chemotherapy AS plan Q21d 3
Group B 1 cycle HIPECS-1 chemotherapy sequential 3 cycles of chemotherapy AS plan Q21d 3 surgeryHIPEC sequential 3 cycles of chemotherapy AS plan Q21d 3
Group C 1 cycle HIPECS-1 chemotherapy sequential 3 cycles of chemotherapy AS plan Q21d 3 HIPECS-1 chemotherapy sequential 3 cycles of chemotherapy AS plan Q21d 3
In this study the patients overall survival was the main evaluation index It is estimated that the case recruitment will be completed in 2 years and the follow-up time will be 3 years The total sample size is approximately 157 cases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None