Actively Recruiting
Response-adapted Total Neoadjuvant Therapy Guided by Induction Chemotherapy in Early- and Intermediate-risk Low Rectal Cancer for Implementation of a Watch-and-wait Strategy
Led by West China Hospital · Updated on 2025-12-03
60
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study investigates the feasibility of an organ-preserving "watch-and-wait" strategy in patients with mid-to-low rectal cancer who achieve a good response after total neoadjuvant therapy (TNT). By retrospectively and prospectively analyzing patients who complete TNT following effective induction chemotherapy, the study aims to assess organ preservation rates and evaluate whether non-surgical management can provide comparable oncologic outcomes to radical surgery while improving functional recovery and quality of life.
CONDITIONS
Official Title
Response-adapted Total Neoadjuvant Therapy Guided by Induction Chemotherapy in Early- and Intermediate-risk Low Rectal Cancer for Implementation of a Watch-and-wait Strategy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Confirmed diagnosis of rectal adenocarcinoma with pMMR/MSS status by immunohistochemistry or genetic testing
- Tumor located 5 cm or less from the anal verge confirmed by examination or MRI
- Clinical stage cT1-3abN0-1M0; patients with cT1N0 suitable for endoscopic resection are excluded
- Mesorectal fascia negative (>1 mm), extramural vascular invasion positive or negative
- No enlarged lateral lymph nodes (less than 7 mm in size)
- Maximum tumor length of 5 cm or less
- Tumor involves two-thirds or less of the circumference
- Tumor length reduction of 30% or more after at least two cycles of XELOX induction chemotherapy
- Completion of total neoadjuvant therapy including 25-28 fractions of radiotherapy and 6-8 cycles of consolidation chemotherapy
- For prospective patients, written informed consent provided
You will not qualify if you...
- History of or current other malignant tumors except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Severely incomplete clinical data preventing effective evaluation
- For prospective patients, refusal to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Z
Ziqiang Wang, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here