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HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy

Sponsor
Zhixin Cao (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05300945
Collaborator
(none)
200
Enrollment
2
Arms
60
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: HIPEC
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Apr 30, 2027

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control
Experimental: HIPEC

Combination Product: HIPEC
HIPEC after gastrectomy with D2 local lymph node dissection.

Outcome Measures

Primary Outcome Measures

  1. Peritoneal recurrence [3 years]

  2. OS [3 years]

    overall survival

Secondary Outcome Measures

  1. DFS [3 years]

    disease free survival

  2. Adverse Events [3 years]

    Number and degree of Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zhixin Cao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhixin Cao, Prof, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT05300945
Other Study ID Numbers:
  • TJ_HIPEC-01
First Posted:
Mar 29, 2022
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Mar 29, 2022