NCT05300945Not yet recruitingPhase 2/3
HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
Source: ClinicalTrials.gov · Last updated 6 Dec 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 20 Mar 2022
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Zhixin Cao
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05300945
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 200
- From 1 Jan 2023 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Serious diseases that are difficult to control
Lab values
- 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
Other
- Severe hepatic and renal dysfunction
- Abnormal coagulation
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.