Abstract 125TiP
Background
Colorectal cancer (CRC) is the third most common malignancy worldwide. Peritoneum recurrence is relatively common in CRC, and patients who progress to peritoneal carcinomatosis (PC) tend to have extremely poor prognosis. How to reduce peritoneal carcinomatosis and improve prognosis still are challenges for clinicians. Existing research have demonstrated that adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) can reduce the risk of peritoneal micrometastasis in ovarian cancer, appendiceal cancer, and gastric cancer, which provide insight in CRC.
Trial design
This study is an open-label, single-center, randomized prospective clinical trial aimed at evaluating whether prophylactic HIPEC can reduce the rate of peritoneal recurrence, prolong survival, and extend disease-free survival in cT3-T4a stage CRC patients with high-risk factors for peritoneal metastasis. Eligible patients are between 18 and 75 years old, with pathologically confirmed colorectal adenocarcinoma, no distant metastasis, eligible for standard curative surgery, ECOG performance status of 0-1, and able to tolerate postoperative HIPEC treatments, and have not received chemotherapy, radiotherapy, or other antitumor treatments prior to the trial. Intraoperatively, tumor lesions will be completely resected with lymphadenectomy performed. These patients will be randomized 1:1 into the experimental group and control group. Patients in experimental group will have four HIPEC catheters placed intraoperatively, and receive the first HIPEC treatment on the day of surgery or the first postoperative day (raltitrexed 4mg, 43°C NS 3000ml, 60 minutes). The second HIPEC treatment will be administered within one week postoperatively (oxaliplatin 130mg/m2, 43°C 5% GS 3000ml). Both groups will receive systemic chemotherapy with CapeOX/capecitabine/mFOLFOX6 as appropriate one month after surgery. The primary endpoint is the 3-year peritoneal recurrence rate; secondary endpoints include 3-year DFS, 3-year and 5-year OS, postoperative quality of life, perioperative complication rates, and HIPEC toxicity (at 1 month and 6 months postoperatively).
Clinical trial identification
Legal entity responsible for the study
C. Chen.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.