## Protocol Section
### Identification Module
**NCT ID:** NCT06434376

**Brief Title:** MRD-positive Colorectal Cancer Patients Combined With Personalized Immune Regulation Diagnosis

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

#### Organization Study ID Info
**ID:** SAHoWMU-CR2024-02-110
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital of Wenzhou Medical University
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Second Affiliated Hospital of Wenzhou Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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

### Conditions Module

**Conditions:**

- Colorectal Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology

**Intervention Names:**

- Biological: Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology

**Label:** Experimental group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

**Description:** 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.

**Name:** Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Exploration of the efficacy of Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology

**Measure:** ORR

**Time Frame:** 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 Outcomes

**Description:** 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

**Measure:** PFS

**Time Frame:** 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

**Description:** 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

**Measure:** OS

**Time Frame:** 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

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** liweiying@pnp-med.com

**Name:** Yaojun Yu

**Phone:** +86 138 6884 9180

**Role:** CONTACT

### IPD Sharing Statement Module

**Description:** publication

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
