Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer (NITDC)

July 17, 2026 updated by: XIAO Yi, MD, Peking Union Medical College Hospital

Efficacy of Neoadjuvant Immunotherapy for T4 Deficient Mismatch Repair (dMMR) Colon Cancer: A Prospective, Single-arm, Phase Ⅱ Clinical Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant immunotherapy
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of R0 resection
Time Frame: Tumour specimen evaluated within 2 weeks after surgery
No tumor infiltration within 1 mm of the surgical margins
Tumour specimen evaluated within 2 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR)
Time Frame: Tumour specimen evaluated within 2 weeks after surgery.
Number of patients with pCR evaluated according to the Mandard tumour regression grading system
Tumour specimen evaluated within 2 weeks after surgery.
diesease-free survival
Time Frame: 3 years
No tumor regrowth or recurrence or metastasis found
3 years
overall survival
Time Frame: 5 years
Refers to the proportion of patients still alive at 5 years after surgery
5 years
Safety and tolerability of Camrelizumab administered
Time Frame: Up to approximately 9 weeks
Determined by the incidence and severity of treatment related adverse events according to CTCAE version 5.0
Up to approximately 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

May 10, 2025

Study Completion (Estimated)

February 10, 2028

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K5121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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