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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with hyperthermic intraperitoneal chemotherapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Mitomycin; Mitomycins

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.