Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer

Launched by SUN YAT-SEN UNIVERSITY · Jul 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with high-risk stage II colorectal cancer that has specific genetic features (dMMR/MSI-H). The researchers want to see if giving two cycles of a medication called Tislelizumab, which blocks a protein that helps tumors evade the immune system, can improve long-term survival compared to the standard treatment. The idea is that this short course of therapy might be enough to reduce the chances of cancer coming back, especially since earlier studies have shown promising results with similar approaches.

To be eligible for the trial, participants need to be between 18 and 80 years old and have had surgery to remove their colorectal cancer. They must have stage II cancer with certain risk factors, like having large tumors or signs of cancer spreading to nearby areas. Participants will receive the treatment and will be monitored for any side effects, but prior studies indicate that the treatment is generally well-tolerated. It's important to know that this trial is currently recruiting participants and aims to find a more effective way to help patients with this type of cancer live longer and healthier lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • dMMR and/or MSI-H colorectal carcinoma that undergo surgical resection
• • Pathologically confirmed as stage II (T3-4,N0), with at least one of the following risk factors: 1) T4 (including T4a and T4b); 2) Vascular invasion; 3) Perineural invasion; 4) Poor differentiation (including mucinous and signet-ring carcinoma); 5) Obstruction and/or perforation before surgery.
• • Perioperative CT/MR/PET-CT find no signs of metastases
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
• • Aged 18-80
• • No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for the current cancer
• • Adequate organ function
• Exclusion Criteria:
• • Active autoimmune disease that has required systemic treatment in past 2 years
• • Positive surgical margin (R1/R2 resection)
• • Presence of post-operative complications that may preclude treatment
• • Active infection requiring systemic therapy
• • Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk \<5%.