Overview

A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
All
Summary
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jing Jin, M.D.
Criteria
Inclusion Criteria:

1. Rectal adenocarcinoma confirmed by histopathology

2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)

3. The age is 18-75 years old, no gender limit

3) The distance between the lower limit of the lesion and the anal margin was less than or
equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1

Exclusion Criteria:

1. History of other malignant tumors;

2. They were allergic to 5-FU, platinum, etc;

3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or
coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic
attack, arteriovenous malformation occurred;

4. After the previous renal history, proteinuria or clinical renal function were found to
be abnormal;

5. History of gastrointestinal fistula, perforation or severe ulcer;

6. At present, there are active infection; clinical obvious heart disease; New York Heart
Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic
arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and
cerebrovascular accident occurred within 6 months before enrollment.