Appendiceal Mucinous Neoplasms
Conditions
Interventions
Intervention group:Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC), administered intraoperatively and postoperatively.
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients with previously untreated appendiceal mucinous neoplasms or those scheduled for complementary surgery for non-recurrent disease who have not undergone prior standard cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC); no prior chemotherapy, radiotherapy, or other antitumor therapies before the clinical trial initiation. 2.Age between 18 and 70 years; 3.Male or non-pregnant, non-lactating female; 4.Peritoneal Carcinomatosis Index (PCI) >= 20 as determined by laparoscopic exploration; 5.Pathologically confirmed (preoperative or intraoperative) low-grade or high-grade appendiceal mucinous neoplasms; 6.Absence of distant metastasis and eligibility for standard radical surgery; 7.Adequate bone marrow reserve, meeting the following hematologic criteria: white blood cell count >= 3.5 × 10^9/L, neutrophil count >= 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 90 g/L; 8.Adequate organ function, meeting the following biochemical criteria: ALT <= 2.5 × upper limit of normal (ULN), AST <= 2.5 × ULN, total bilirubin <= 1.5 × ULN, and serum creatinine <= 1.5 × ULN; 9.Voluntary provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Appendiceal tumors of pathological types other than mucinous neoplasms; 2.History of other malignant tumors within the past 5 years; 3.Postoperative Completeness of Cytoreduction Score (CCS) of 2 or 3; 4.Presence of severe or uncontrolled medical conditions or infections (including atrial fibrillation, angina, cardiac insufficiency, ejection fraction < 50%, refractory hypertension, etc.); 5.Patients requiring treatment for epileptic seizures (e.g., steroid or antiepileptic therapy); 6.Patients with severe or uncontrolled psychiatric disorders; 7.History of substance abuse, or medical, psychological, or social conditions that may interfere with study participation or evaluation of study results; 8.Any unstable condition that may compromise patient safety or compliance; 9.Concurrent use of anticancer drugs as part of another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival rate after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate after operation;Incidence of Adverse Events (Intraoperative and within 30 Days Postoperative); | — |
Countries
China
Contacts
Public ContactZhang Yong
Zhongshan Hospital, Fudan University
Outcome results
None listed