HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HIPEC.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Peritoneal Metastases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Combination product HIPEC
HIPEC after gastrectomy with D2 local lymph node dissection.
Primary outcome measures
- Peritoneal recurrence [Time frame: 3 years]
- OS [Time frame: 3 years]
Secondary outcome measures (2)
- DFS [Time frame: 3 years]
- Adverse Events [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05300945 · TJ_HIPEC-01