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

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Apr 9, 2021

Keywords

ClinConnect Summary

This clinical trial is designed to compare two chemotherapy drugs, Mitomycin and Lobaplatin, in patients with advanced colorectal cancer who are undergoing surgery and a special type of chemotherapy called hyperthermic intraperitoneal chemotherapy (HIPEC). The goal is to see which drug is more effective in helping patients after they have had surgery to remove their cancer. The study is being conducted at Wuhan Union Hospital and is currently not recruiting participants.

To be eligible for this trial, participants must be between 18 and 75 years old, have a confirmed diagnosis of colorectal adenocarcinoma (a type of cancer), and be in a certain stage (T3 or higher) that allows for surgery. They should not have had any other cancer treatments before joining the trial and need to have normal organ function. If you or someone you know meets these criteria and is interested in participating, the study could provide a chance to receive either of the two medications and contribute to important research in cancer treatment.

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Eligibility criteria

• Inclusion Criteria:
• • 1. No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;
• • 2. Aged 18-75 years;
• • 3. Male or non-pregnant or lactating women;
• • 4. Pathological diagnosis of colorectal adenocarcinoma;
• • 5. Clinical diagnosis of T3 stage or above without distant metastasis and can be given radical surgery (AJCC Version 8, 2018);
• • 6. Normal function of major organs;
• 7. 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;
• 8. 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);
• • 9. ECOG score 0-1;
• Exclusion Criteria:
• • 1. A history of other malignant tumors within 5 years;
• • 2. Distant metastasis found during surgery;
• • 3. Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;
• • 4. Suffering from epilepsy or other mental illness, unable to control behavior;
• • 5. Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;
• • 6. Pregnant or lactating women.
• • 7. Receiving anti-cancer drug therapy from other clinical trials.