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Active, not recruitingNCT06215677NITDCUpdated Jul 21, 2026

Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer

A Phase 2 interventional study of Camrelizumab in Colon Cancer, Mismatch Repair Deficiency and Immunotherapy, sponsored by Peking Union Medical College Hospital. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Colon Cancer
  • Mismatch Repair Deficiency
  • Immunotherapy
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 18 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    Neoadjuvant immunotherapy

    Drug: Camrelizumab

Interventions

  • DrugCamrelizumab

    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.

06

What researchers measure

Primary outcomes

  1. the rate of R0 resection

    No tumor infiltration within 1 mm of the surgical margins

    Time frame: Tumour specimen evaluated within 2 weeks after surgery

Secondary outcomes

  1. Pathological complete response (pCR)

    Number of patients with pCR evaluated according to the Mandard tumour regression grading system

    Time frame: Tumour specimen evaluated within 2 weeks after surgery.

  2. diesease-free survival

    No tumor regrowth or recurrence or metastasis found

    Time frame: 3 years

  3. overall survival

    Refers to the proportion of patients still alive at 5 years after surgery

    Time frame: 5 years

  4. Safety and tolerability of Camrelizumab administered

    Determined by the incidence and severity of treatment related adverse events according to CTCAE version 5.0

    Time frame: Up to approximately 9 weeks

07

Study locations

2 sites
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
  • Peking Union Medical College Hospital
    Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06215677
Lead sponsor
Peking Union Medical College Hospital
Responsible party
XIAO Yi, MD (Director, Head of Colorectal surgery, Principal Investigator, Clinical Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Jan 22, 2024
Start date
Jan 1, 2024
Primary completion
May 10, 2025
Completion
Feb 10, 2028 (estimated)
Last update
Jul 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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