peritoneal metastasis of colorectal cancer, peritoneal metastases of appendiceal cancer
Conditions
Interventions
Conversion therapy group (HIPEC-ICIs-TD-CTH group):Initial Laparoscopic Exploration and HIPEC Catheter Placement:
Patients underwent laparoscopic exploration under general anesthesia with PCI scoring.
3000~3500 mL normal saline at 43°C, flow rate 400 mL/min, duration 60 minutes). Bevacizumab 300 mg was administered intraperitoneally on D5 in 500 mL normal saline. Perfusion catheters were removed up
3. Targeted Therapy Regimen: Bevacizumab or cetuximab was selected based on tumor location and NGS results (cetuximab administered biweekly)
4. ICIs Regimen: Sintilimab 200 mg IV on D2
CTLA-4 inhibitor (tremelimumab/durvalumab): 1 mg/kg IV on D2 (maximum 4 cycles).
The number of conversion therapy cycles was unlimited, with imaging assessment required every 2~4 cycles. Efficacy was
2. For patients with partial response but still not amenable to CRS, exploration was terminated, and the original conversion regimen or second-line therapy was continued. Postoperative maintenance che
Sponsors
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed peritoneal metastasis (PM) from synchronous or metachronous colorectal malignancies or appendiceal mucinous tumors, who have not received prior anti-tumor treatment or have completed anti-tumor treatment with a washout period of >=1 month before study enrollment; 2. Age 18-75 years; Eastern Cooperative Oncology Group (ECOG) performance status: 0-2; 3. Non-extensive peritoneal metastasis (Peritoneal Cancer Index [PCI] =3.5×10^9/L, absolute neutrophil count>=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90 g/L; 5. Adequate organ function with the following biochemical parameters: alanine aminotransferase (ALT) ?=2.5×ULNupper limit of normal, aspartate aminotransferase (AST) ?=2.5×ULN, total serum bilirubin ?=1.5×ULN, serum creatinine ?=1.5×ULN.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Severe intra-abdominal adhesions due to any cause; 2. Uncontrolled medical conditions or infections (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction <50%, refractory hypertension, etc.); 3. Patients with seizure disorders requiring treatment (such as corticosteroids or anti-epileptic therapy) or patients with severe or uncontrolled psychiatric disorders; 4. Any unstable condition that may compromise patient safety or compliance; 5. Patients who fail to complete the study protocol; 6. Patients who violate study protocol requirements; 7. Patients with poor data recording quality, incomplete, or inaccurate documentation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion Surgery Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-Year Overall Survival Rate ;Treatment safety; | — |
Countries
China
Contacts
Public ContactZhu Xi
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Outcome results
None listed