Back to resultsHIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
Primary Purpose
Gastric Cancer, Peritoneal Metastases
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HIPEC
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- histologically proven adenocarcinoma of stomach
- stage cT3-4N+M0
- no involvement of esophagus > 3 cm
- ECOG (Eastern Cooperative Oncology Group) : 0~1
- no previous chemotherapy or radiotherapy for any malignancy
- no previous surgery for GC excluding endoscopic mucosal resection or endoscopic submucosal dissection
- Signed the Informed Consent Form
Exclusion Criteria:
- Serious diseases that are difficult to control
- Severe hepatic and renal dysfunction
- Abnormal coagulation
- The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
HIPEC
Arm Description
Outcomes
Primary Outcome Measures
Peritoneal recurrence
OS
overall survival
Secondary Outcome Measures
DFS
disease free survival
Adverse Events
Number and degree of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05300945
Brief Title
HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
Official Title
HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhixin Cao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Patients with stage cT3-4N+M0 gastric cancer were recommended to receive neoadjuvant chemotherapy before radical surgery in terms of the eradication of micrometastasis in addition to local control, higher compliance with intensive chemotherapy, and avoidance of futile surgery by detection of initially invisible distant metastasis after rapid disease progression. However, in some studies, gastrectomy followed by neoadjuvant chemotherapy failed to demonstrate survival benefits for these patients. And peritoneal recurrence was the most common and devastating reason. Hyperthermic intraperitoneal chemotherapy (HIPEC) was introduced for peritoneal cancer last century. A few studies suggested HIPEC could improve prognosis in patients with limited peritoneal metastasis from various cancer. In summary, we conducted this study to confirm the efficacy and safety of HIPEC after gastrectomy in patients with advanced gastric cancer received neoadjuvant chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Peritoneal Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
HIPEC
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
HIPEC
Intervention Description
HIPEC after gastrectomy with D2 local lymph node dissection.
Primary Outcome Measure Information:
Title
Peritoneal recurrence
Time Frame
3 years
Title
OS
Description
overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
DFS
Description
disease free survival
Time Frame
3 years
Title
Adverse Events
Description
Number and degree of Adverse Events
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically proven adenocarcinoma of stomach
stage cT3-4N+M0
no involvement of esophagus > 3 cm
ECOG (Eastern Cooperative Oncology Group) : 0~1
no previous chemotherapy or radiotherapy for any malignancy
no previous surgery for GC excluding endoscopic mucosal resection or endoscopic submucosal dissection
Signed the Informed Consent Form
Exclusion Criteria:
Serious diseases that are difficult to control
Severe hepatic and renal dysfunction
Abnormal coagulation
The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication.
IPD Sharing Time Frame
For 1 year after publishing the results in a journal.
Learn more about this trial
HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
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