Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

Hyperthermic intraperitoneal chemotherapy (HIPEC) is traditionally used to treat peritoneal cancer combined with cytoreductive surgery (CRS). Further, there have been more than 20 years for CRS + HIPEC applying in treatment of patients with colorectal cancer peritoneal metastasis. While, to date, the kinds, doses, combinations of HIPEC drugs are not clearly been evaluate a criterion for local advanced colorectal cancer patients. Thus, This study aim to compare the efficacy of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with HIPEC. We plan to recruit 201 patients and divide into 3 groups, 2 drug groups and 1 control group, radomly. all patients with advanced co cancer receive radical surgery + HIPEC + mFOLFOX6/XELOX chemotherapy regimen. the mainly experimental variable is HIPEC drugs and three groups employ Mitomycin, Lobaplatin and none respectively. the endpoints of study include peritoneal metastasis, overall survival, immune status and perioperative safety assessment.

Inclusion criteria

• No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;
• Aged 18-75 years;
• Male or non-pregnant or lactating women;
• Pathological diagnosis of colorectal adenocarcinoma;
• Clinical diagnosis of T3 stage or above without distant metastasis and can be given radical surgery (AJCC Version 8, 2018);
• Normal function of major organs;
• Routine blood examinations meeting the following criteria:

A. HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L;

• Chemistry indexs meeting the following criteria:

A. TBIL < 1.5ULN; B. ALT and AST < 2.5ULN; ALB > 30 g/L C. serum Cr ≤ 1.25 ULN or endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula);

• ECOG score 0-1;

Exclusion criteria

• A history of other malignant tumors within 5 years;
• Distant metastasis found during surgery;
• Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;
• Suffering from epilepsy or other mental illness, unable to control behavior;
• Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;
• Pregnant or lactating women.
• Receiving anti-cancer drug therapy from other clinical trials.