NCT05753306RecruitingPhase 2
Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 22 Feb 2023
- Start date
- Apr 2023
- Primary completion date
- Mar 2030
- Lead sponsor
- Mayo Clinic
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05753306
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From Apr 2023 to the primary completion date, Mar 2030
- 1 site in 1 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
- Comorbidities that would preclude protocol therapy
Other illness
- Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc)
- Malignant ascites at time of study enrollment
- Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Other
- Subjects deemed unable to comply with study and/or follow-up procedures
Who the study is looking for
- Restricted to 18 to 80 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II/III gastroesophageal (GE) junction adenocarcinomas
- Absolute neutrophil count \>= 1,500 / uL
- Platelets \>= 50,000 / Ul
- Serum creatinine \<= 1.5 mg / dL
- Adequate nutritional status (Albumin \>= 3.5)
- Metastasis confined to the peritoneum:
- Positive peritoneal cytology
- Peritoneal metastasis on diagnostic laparoscopy
- Peritoneal metastasis on imaging
- Response to systemic chemotherapy defined as at least one of the following:
- Reduction (\>= 30%) in standardized uptake value (SUV) max \[Response Evaluation Criteria in Solid Tumors (RECIST) criteria\]
- Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (\>= 20% decrease in the longest diameter of target lesion) RECIST criteria
- Reduction ( \>= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology
- Reduction ( \>= 30%) in serum tumor markers CEA or CA 19-9
- Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeon deems high likelihood for a complete cytoreduction
- Body Mass Index (BMI) =\< 35 kg/m\^2
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.