Evaluating watch and wait strategy versus surgery after immunotherapy for advanced colorectal cancer
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(WINDOW): A Single-center, Open-label, Prospective, Phase II Clinical Trial.
This study is testing if some patients with advanced colorectal cancer can safely skip surgery after immunotherapy and just be monitored to see how well they respond to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Yunnan Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Kunming, Yunnan) |
| Trial ID | NCT06477991 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of a watch and wait strategy, guided by dynamic monitoring of minimal residual disease (MRD), following neoadjuvant immunotherapy in patients with locally advanced colorectal cancer characterized by deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H). The study aims to determine the clinical complete response rate without immediate surgery, potentially allowing for a less invasive approach. Participants will be closely monitored to assess their response to treatment and the presence of residual disease.
Who should consider this trial
Good fit: Ideal candidates include individuals with locally advanced colorectal adenocarcinoma who have not undergone prior surgery, chemotherapy, or radiotherapy and are confirmed to have dMMR or MSI-H characteristics.
Not a fit: Patients with distant metastasis or those who have previously received treatment for colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with advanced colorectal cancer, potentially improving their quality of life.
How similar studies have performed: While the approach of monitoring MRD in colorectal cancer is gaining interest, this specific strategy of watch and wait after immunotherapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ( 1 ) Disease characteristics 1. Histologic confirmation for colorectal adenocarcinoma; 2．Immunohistochemical identified as dMMR and/or pCR and/or NGS detection for MSI-H; 3．According to UICC/AJCC TNM staging system (in 2017 version 8) assessment for locally advanced colorectal cancer (II - III, namely cT3-4 and/or N + ）； 4.\* clinical staging methods: colon CT staging, approved by pelvic magnetic resonance imaging (MRI) and the rectum rectum cavity ultrasound combined with staging, 5．No signs of intestinal obstruction;Or intestinal obstruction after proximal colon obstruction has been relieved after colostomy surgery; 6．No distant metastasis was confirmed by comprehensive examination (distant organs or (and) the distant lymph node metastasis); ( 2 ) Previous treatment 1．No colorectal cancer surgery before; 2. No previous chemotherapy or radiotherapy ; 3. had not received biological treatment ; 4. Previous endocrine therapy : no restriction. Exclusion Criteria: * 1.Immunohistochemistry of tumor biopsy specimens suggested pMMR or microsatellite instability detection suggested MSS ; 2. Chronic hepatitis B or C ( high-copy viral DNA ) with a history of HIV infection or active phase ; 3.Autoimmune diseases ; 4.Other active clinical severe infections ( \> NCI-CTC3.0 version ) ; 5. patients with clinical stage I ; 6.Preoperative evidence of distant metastasis ; 7. cachexia, organ dysfunction ; 8. Have a history of pelvic or abdominal radiotherapy ; 9. Patients whose seizures require treatment ( e.g. steroids or antiepileptic treatment ) ; 10.5 years have a history of other malignant tumors, except for cured cervical carcinoma in situ or skin basal cell carcinoma ; 11. Chronic inflammatory bowel disease, intestinal obstruction ; 12. Drug abuse and medical, psychological or social conditions may interfere with patient participation in the study or have an impact on the evaluation of the results of the study ; 13.Known or suspected allergies to the study drug or any drug related to this test ; any unstable condition or condition that may endanger patient safety and compliance ;
Where this trial is running
Kunming, Yunnan
- Yunnan Cancer Hospital — Kunming, Yunnan, China (Recruiting)
Study contacts
- Study coordinator: Xuan Zhang, doctor
- Email: zhangxuan66@kmmu.edu.cn
- Phone: +86 173 8791 1546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.