Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Calcium; Calcium, Dietary; Capecitabine; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin; Raltitrexed

Criteria

Inclusion Criteria:

• Joined the study voluntarily and signed informed consent form

• Eastern Cooperative Oncology Group performance status of 0 to 1

• Life expectancy of more than 5 years

• Colorectal adenocarcinoma / mucinous adenocarcinoma / signet ring cell cancer confirmed by histopathology

• Stage T4NanyM0 cancer; or stage T3NanyM0 mucinous adenocarcinoma / signet ring cell cancer / adenocarcinoma with partly mucinous adenocarcinoma or signet ring cell cancer

• R0 resection of colorectal cancer

• Neutrophils (ANC) ≥ 1.5×10^9/L, Platelet count (Pt) ≥ 100× 10^9/L, Hemoglobin (Hb) ≥ 80 g/L, Hepatic function: ALT and AST ≤ 2.5 times upper limit of normal (ULN) and TBIL ≤ 1.5 times ULN, Renal function: creatinine ≤ 1.5 times ULN

• Use of an effective contraceptive for adults to prevent pregnancy

Exclusion Criteria:

• Rectal cancer below peritoneal reflection (≤ 8cm above the anal verge)

• Other malignant tumors within the past 5 years, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived from radical treatment

• Severe adhesion of peritoneal cavity impossible to separate

• Abdominal infection

• Allergic to raltitrexed, 5-FU, and oxaliplatin; Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency

• Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior

• Drug addiction, Alcoholism or AIDS

• Impossible to tolerate the operation due to severe cardiac, lung, and vascular diseases

• Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives