NCT06525714Not yet recruitingEarly phase 1
Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer
Effect of Prophylactic Hyperthermic Intraperitonal Chemotherapy（HIPEC）After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer（cT3N+M0 and cT4aN+/-M0）: A Randomized-controlled Study
Source: ClinicalTrials.gov · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study focuses on patients with locally advanced gastric adenocarcinoma (cT3N+M0 and cT4aN+/-M0), assessing the feasibility, surgical safety, and oncological benefit of prophylactic HIPEC treatment following laparoscopic D2 radical surgery.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 302 (estimated)
- First submitted
- 25 Jul 2024
- Start date
- Aug 2024
- Primary completion date
- Jul 2029
- Lead sponsor
- The First Hospital of Jilin University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06525714
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 302
- From Aug 2024 to the primary completion date, Jul 2029
- 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.
Prior treatment
- Distant metastasis (M1) found during surgery;
- Receiving other chemotherapy, radiotherapy, or immunotherapy;
Other illness
- Other cancers within the past 5 years;
- Severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction, or severe underlying diseases that make the patient unable to tolerate surgery;
- A history of severe mental illness;
- History of taking steroid medications;
Other
- ASA (American Society of Anesthesiologists) classification ≥IV and/or ECOG performance status \>2;
- Lack of written informed consent;
Who the study is looking for
- Age \>18 and ≤70 years;
- Male or nonpregnant female;
- Gastric adenocarcinoma cT3N+M0 and cT4aN+/-M0 (according to the 8th edition of the AJCC TNM staging system);
- No distant metastasis, suitable for D2 lymph node dissection;
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;
- No prior cytotoxic chemotherapy, radiotherapy, or immunotherapy;
- Written informed consent given before any study-related procedures;
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.