Actively Recruiting
The Efficacy of Watch and Wait Strategy or Surgery After Neoadjuvant Immunotherapy for Locally Advanced Colorectal Cancer With dMMR/MSI-H Guided by MRD Dynamic Monitoring: A Single-center, Open-label, Prospective, Phase II Clinical Trial.
Led by Yunnan Cancer Hospital · Updated on 2024-06-27
22
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single arm, single center, phase II, prospective clinical study aimed at exploring the effectiveness and safety of watch and wait strategy guided by dynamic minimal disease residual (MRD) monitoring to achieve clinical complete response after neoadjuvant immunotherapy for locally advanced colorectal cancer with deficient mismatch repair/ microsatellite instability-high (dMMR/MSI-H).
CONDITIONS
Official Title
The Efficacy of Watch and Wait Strategy or Surgery After Neoadjuvant Immunotherapy for Locally Advanced Colorectal Cancer With dMMR/MSI-H Guided by MRD Dynamic Monitoring: A Single-center, Open-label, Prospective, Phase II Clinical Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic confirmation of colorectal adenocarcinoma
- Tumor identified as deficient mismatch repair (dMMR) and/or microsatellite instability-high (MSI-H) by immunohistochemistry or genetic testing
- Locally advanced colorectal cancer staging II-III (cT3-4 and/or N+)
- Clinical staging by colon CT, pelvic MRI, and rectal ultrasound
- No signs of intestinal obstruction or obstruction relieved by colostomy
- No confirmed distant metastasis by comprehensive examination
- No prior colorectal cancer surgery
- No previous chemotherapy, radiotherapy, or biological treatment
- No restriction on prior endocrine therapy
- Age between 18 and 75 years
You will not qualify if you...
- Tumor biopsy shows proficient mismatch repair or microsatellite stable status
- Chronic hepatitis B or C with high viral load, history of HIV, or active infection
- Autoimmune diseases
- Other active severe clinical infections
- Clinical stage I colorectal cancer
- Evidence of distant metastasis before treatment
- Cachexia or organ dysfunction
- History of pelvic or abdominal radiotherapy
- Seizures requiring treatment
- History of other malignant tumors within 5 years except cured cervical carcinoma in situ or skin basal cell carcinoma
- Chronic inflammatory bowel disease or intestinal obstruction
- Drug abuse or medical, psychological, or social conditions affecting participation
- Known or suspected allergies to study drug or related drugs
- Any unstable condition that risks patient safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Actively Recruiting
Research Team
X
Xuan Zhang, doctor
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
0
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