A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer

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

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborators: Beijing Cancer Hospital; Cancer Hospital of Guizhou Province; Jilin Provincial Tumor Hospital; Peking Union Medical College Hospital; Xijing Hospital

Criteria

Inclusion criteria:

1. 18-75 years old, regardless of gender

2. Histologically confirmed rectal adenocarcinoma;

3. Up to 12 cm above the anal verge on the basis of rigid rectoscopy.

4. MRI of the rectum is acceptable;

5. Patients in stage II or III rectal cancer are eligible if any of the following criteria are fulfilled: Categories T3,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement.

6. ECOG score 0-1.

Exclusion Criteria:

1. History of malignant tumor in other parts;

2. Cannot complete MRI; Allergic to 5-fu drugs; Allergic to platinum drugs;

3. During thrombolytic and anticoagulant therapy, the patient has bleeding diathesis or coagulation dysfunction; Or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year;

4. History of kidney, urine test found proteinuria or clinical renal function was significantly abnormal;

5. History of digestive tract fistula, perforation or severe ulcer;

6. Active infection is present; Clinically obvious heart disease; New York heart association (NYHA) of Ⅱ level or congestive heart failure; Unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.