Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer

Last updated: August 30, 2025
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Colorectal Cancer

Vaccines

Treatment

Camrelizumab

Clinical Study ID

NCT06215677
K5121
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 adjacentorgans or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resectioncannot achieve according to intraoperative exploration;

  6. No evidence of distant metastasis;

  7. Newly treated patients who have not received treatment including chemotherapy andsurgery;

  8. Liver, kidney and other organs have good function and can tolerate chemotherapy andsurgery;

  9. Patients and family members can understand the study protocol, voluntarilyparticipate in the study and sign informed consent.

Exclusion

Exclusion Criteria:

  1. A history of other malignant tumors (other than cured basal cell carcinoma, cervicalcarcinoma in situ, surgically treated localized prostate cancer, or surgicallyresected breast ductal carcinoma in situ) within the past 5 years;

  2. Complicated with intestinal obstruction, intestinal perforation, gastrointestinalbleeding and other patients requiring emergency surgery; pregnant or lactatingwomen;

  3. Patients with a history of severe mental illness, immune disease, hormonemedication;

  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 Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Camrelizumab
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
February 10, 2030

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing,
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing 1816670,
    China

    Active - Recruiting

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