Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer

NCT ID: NCT06215677

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2030-02-10

Brief Summary

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Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.

Detailed Description

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Conditions

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Colon Cancer Mismatch Repair Deficiency Immunotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant immunotherapy

Group Type EXPERIMENTAL

Camrelizumab

Intervention Type DRUG

Camrelizumab 200mg for 3 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of immunotherapy, type and extent of the surgery will be selected by the surgeon.

Interventions

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Camrelizumab

Camrelizumab 200mg for 3 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of immunotherapy, type and extent of the surgery will be selected by the surgeon.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged 18-75 years;
2. ECOG score 0-2;
3. Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;
4. Tumor located in cecum, ascending colon, transverse colon and sigmoid colon;
5. Patients with clinical stage cT4: (1) Loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resection cannot achieve according to intraoperative exploration;
6. No evidence of distant metastasis;
7. Newly treated patients who have not received treatment including chemotherapy and surgery;
8. Liver, kidney and other organs have good function and can tolerate chemotherapy and surgery;
9. Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.

Exclusion Criteria

1. A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;
2. Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women;
3. Patients with a history of severe mental illness, immune disease, hormone medication;
4. Patients contraindicated by immunotherapy or surgery;
5. Participated in other clinical researchers in the past 3 months;
6. Any other circumstances that the investigator considers inappropriate for inclusion.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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XIAO Yi, MD

Director, Head of Colorectal surgery, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen Sun, M.D.

Role: CONTACT

+86-18910598831

Facility Contacts

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Zhen Sun

Role: primary

Zhen Sun, M.D.

Role: primary

+86-18910598831

Other Identifiers

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K5121

Identifier Type: -

Identifier Source: org_study_id

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