Neoadjuvant immunotherapy for advanced colon cancer with specific genetic features

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

This study is testing a new immunotherapy treatment for patients with advanced colon cancer that has specific genetic features to see if it can help remove tumors more effectively without harming nearby organs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06215677 on ClinicalTrials.gov

What this trial studies

This study investigates the use of neoadjuvant immunotherapy, specifically camrelizumab, in patients with T4 colon cancer characterized by mismatch repair deficiency (dMMR). The goal is to determine if this treatment can improve the rate of complete tumor resection (R0) while preserving adjacent organs, as these patients typically do not respond well to standard chemotherapy. Eligible participants are newly diagnosed patients who have not received prior treatment and have specific tumor characteristics. The study aims to provide a new therapeutic option for a challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed dMMR colon adenocarcinoma at clinical stage cT4 who have not undergone prior treatment.

Not a fit: Patients with a history of other malignancies or those with distant metastasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance surgical outcomes and overall survival for patients with advanced dMMR colon cancer.

How similar studies have performed: While immunotherapy has shown promise in various cancers, this specific approach for T4 dMMR colon cancer is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Zhen Sun, M.D.

Conditions Colon Cancer; Mismatch Repair Deficiency; Immunotherapy