MRD-positive Colorectal Cancer Patients Combined With Personalized Immune Regulation Diagnosis

Study on Adjuvant Treatment of MRD-positive Colorectal Cancer Patients With Routine Chemotherapy Combined With Personalized Immune Regulation Diagnosis and Treatment Technology

Establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy: Patients with MRD positive and high risk of recurrence after colorectal cancer surgery were enrolled. Surgical tumor tissue and blood samples were collected, tumor tissue samples were sequenced, neoantigens were analyzed, personalized immunomodulators were prepared, and routine adjuvant therapy combined with personalized immunomodulatory diagnosis and treatment technology were performed to prevent postoperative recurrence. To establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325024
      • No 1111 Wenzhou Avenue (East Section), Longwan District, Wenzhou City, Zhejiang Province, China

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. They must give informed consent, indicating that they understand the purpose of the study and the procedures required, and are willing to participate in the study.
2. Age 18-80.
3. Pathological examination confirmed colorectal adenocarcinoma.

4. For patients with stage II with high risk factors or stage III with radical surgery, stage II (high risk) colon cancer is defined as (any of):

   a )T4 b)≥ Level 3 c) The clinical manifestations are intestinal obstruction or intestinal perforation d) Histological signs of vascular, lymphatic, or perineural invasion e) Check < 12 nodes

5. Patients with liver or lung metastases that can be resected in one stage with the primary lesion.
6. There must be sufficient formalin to fix the tumor material in the paraffin embedded (FFPE) block or section tissue (only after sponsor approval), preferably obtained from excision.
7. Patients should meet the following biochemical indicators: total bilirubin ≤2× upper limit of normal (ULN); AST and ALT≤2× upper limit of normal (ULN); Creatinine clearance ≥60 ml/min.
8. Patients should meet the following hematological indicators: neutrophil count ≥1.5×109 /L; Hemoglobin ≥10.0 g/dL; Platelet count ≥100×109 /L.
9. Expected survival ≥ 3 months.
10. Postoperative ctDNA MRD test was positive, routine blood indexes were negative, and imaging was negative.

Exclusion Criteria:

1. Stage I patients and stage II patients without risk factors or MSI-H.
2. Stage IV patients who cannot be surgically resected.
3. Patients with liver, kidney, heart, lung and other dysfunction, unable to tolerate surgery or unable to complete follow-up chemotherapy.
4. Patients who refuse adjuvant therapy such as chemotherapy, are allergic to chemotherapy drugs and have poor compliance.
5. Patients who have received other immunotherapy within 1 month (such as immune checkpoint inhibitor therapy, therapeutic antibody therapy, immune cell therapy, and immune system modulator therapy)

6. Patients with a known past or current malignancy, except where a diagnosis is included, except in the following cases:

   1. Stage 1B or below cervical cancer.
   2. Non-invasive basal cell or squamous cell skin cancer.
   3. Non-invasive superficial bladder cancer.
   4. Prostate cancer with a current PSA level < 0.1 ng/mL.
   5. Any curable cancer with a complete response (CR) duration of > 2 years.
7. Patients with hematological and autoimmune diseases.
8. Patients with active hepatitis B or C.
9. Patients affected by drug abuse, clinical or psychological or social factors that make informed consent or the implementation of research.
10. Pregnant and lactating women.
11. Patients with mental illness, senile dementia, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental group; Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology

Biological: Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology; Blood samples were collected for MRD detection within one month (week 3) after colorectal cancer surgery, and MRD-positive patients were selected for routine chemotherapy (course of 6 months). Blood and tumor tissue samples of enrolled patients were collected, and relevant clinical data were recorded. The whole exon and expression profile of surgical tumor tissue samples were sequenced, neoantigens were analyzed, and immunomodulators were prepared. After the preparation of individualized immunomodulators, combined treatment was performed simultaneously with chemotherapy. During the treatment process, patients' response to treatment and survival were observed, and tumor load, ctDNA changes, imaging and other indicators before and after treatment were compared. To evaluate the efficacy of immunotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Exploration of the efficacy of Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology	Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Observe and evaluate the progression free survival (PFS) of Postoperative MRD positive patients with with routine chemotherapy combined with personalized immune regulation diagnosis and treatment technolog	Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
OS	Observe and evaluate the overall survival(OS) of Postoperative MRD positive patients with with routine chemotherapy combined with personalized immune regulation diagnosis and treatment technology	Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SAHoWMU-CR2024-02-110

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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