NCT06215677

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
45mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jan 2024Feb 2030

Study Start

First participant enrolled

January 1, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2030

Expected
Last Updated

September 5, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

January 9, 2024

Last Update Submit

August 30, 2025

Conditions

Colon CancerMismatch Repair DeficiencyImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • the rate of R0 resection

    No tumor infiltration within 1 mm of the surgical margins

    Tumour specimen evaluated within 2 weeks after surgery

Secondary Outcomes (4)

  • Pathological complete response (pCR)

    Tumour specimen evaluated within 2 weeks after surgery.

  • diesease-free survival

    3 years

  • overall survival

    5 years

  • Safety and tolerability of Camrelizumab administered

    Up to approximately 9 weeks

Study Arms (1)

Neoadjuvant immunotherapy

EXPERIMENTAL
Drug: Camrelizumab

Interventions

CamrelizumabDRUG

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.

Neoadjuvant immunotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75 years;
  • ECOG score 0-2;
  • Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;
  • Tumor located in cecum, ascending colon, transverse colon and sigmoid colon;
  • 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;
  • No evidence of distant metastasis;
  • Newly treated patients who have not received treatment including chemotherapy and surgery;
  • Liver, kidney and other organs have good function and can tolerate chemotherapy and surgery;
  • Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.

You may not qualify if:

  • 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;
  • Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women;
  • Patients with a history of severe mental illness, immune disease, hormone medication;
  • Patients contraindicated by immunotherapy or surgery;
  • Participated in other clinical researchers in the past 3 months;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Colonic NeoplasmsTurcot syndrome

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Zhen Sun, M.D.

CONTACT

+86-18910598831sunzhen0906@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Colorectal surgery, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 22, 2024

Study Start

January 1, 2024

Primary Completion

May 10, 2025

Study Completion (Estimated)

February 10, 2030

Last Updated

September 5, 2025

Record last verified: 2025-05

Locations

CN(2)