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. (WINDOW)

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 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).

Study Overview

• Status: Recruiting
• Conditions: Clinical Complete Response Rate With Negative MRD
• Intervention / Treatment: Drug: Tireilizumab（PD-1 inhibitor）

• Study Type: Observational
• Enrollment (Estimated): 22

Contacts and Locations

• Study Contact: Name: Xuan Zhang, doctor; Phone Number: +86 173 8791 1546; Email: zhangxuan66@kmmu.edu.cn

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Recruiting
      • Yunnan Cancer Hospital
      • Contact: Xuan Zhang, doctor; Phone Number: +86 173 8791 1546; Email: zhangxuan66@kmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

( 1 ) Patient characteristics

1. Age : 18-75 years old ;
2. Physical status score : ECOG 0-1 ;
3. Life expectancy : more than 2 years ;
4. hematology : WBC > 4000 / mm3 ; pLT > 100000 / mm3 ; hb should be > 10g / dL in principle ; chronic anemia ( hemoglobin < 10.0 g / dL ) is not an exclusion criterion but should be corrected by blood transfusion before surgery and chemotherapy. If hemoglobin remains low after transfusion, surgery and chemotherapy can be decided by surgical and medical teams.
5. Liver function : SGOT and SGPT were less than 1.5 times of normal value ; bilirubin less than 1.5 mg / dL ;
6. Renal function : creatinine < 1.8mg / dL ;

Description

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 ;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical complete response rate with negative MRD	Clinical complete response rate with negative MRD	2023/10/30-2026/10/30

Collaborators and Investigators

• Sponsor: Yunnan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors
• Other Study ID Numbers: YJZ2023-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No