Clinical trial NCT07012538: RASi for Preventing Postoperative Recurrence of Stage II/III Colon Cancer
Official title: Renin-angiotensin System Inhibitor for Preventing Postoperative Recurrence of Stage II/III Colon Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer (Stage II &Amp;Amp; III)
Keywords: renin-angiotensin system inhibitor
colon cancer
disease-free survival
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 2640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypertension and stage II/III colon cancer, received radical resection of the primary tumor.

Brief summary: The goal of this retrospective cohort study is to learn about the long-term effects of renin-angiotensin system inhibitors (RASi) in preventing patients with hypertension and stage II/III colon cancer from recurrence and metastases after radical resection. The main question it aims to answer is:

Does RASi improve the 3-year disease-free survival of patients with hypertension and stage II/III colon cancer after surgery? Participants with hypertension and already having radical resection of stage II/III colon cancer will be followed up for 3 years.

Detailed description: Previous studies have shown that renin-angiotensin system inhibitors (RASi) may reduce postoperative recurrence and metastases of colorectal cancer. However, the relevant clinical evidences were low level and controversial. This study retrospectively collect patients with hypertension and stage II/III colon cancer after radical resection, and compare the patients with vs. without RASi in terms of long-term oncological outcomes, to study the inhibitory effect of RASi on recurrence and metastasis.

Eligibility criteria: Inclusion Criteria:

1. Inferior tumor edge \> 15 cm from anal verge;
2. Received radical resection of primary tumor;
3. Pathological proved stage II or stage III adenocarcinoma;
4. No evidence of distant metastases at time of surgery (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, intraoperative exploration, etc;
5. Combined with hypertension at time of surgery;
6. No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
7. Informed consent.

Exclusion Criteria:

1. Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
2. Multiple primary colorectal cancer;
3. Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
4. Co-existent inflammatory bowel disease;
5. Pregnancy or lactation;
6. Received any of preoperative anti-cancer treatment.

Primary outcomes:
measure: 3-year disease-free survival
timeFrame: 3 years after surgery
Secondary outcomes:
Other outcomes:
measure: 3-year overall survival
timeFrame: 3 years after surgery
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
References: