OncoMatch/Clinical Trials/NCT06520683
Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer
Is NCT06520683 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Tislelizumab and Adjuvant chemotherapy for colorectal cancer.
Treatment: Tislelizumab · Adjuvant chemotherapy — This open-label phase III trial investigates the efficacy of two cycles of PD-1 blockade (Tislelizumab) as adjuvant therapy to see how it works compared with standard of care (SOC) in treating patients with stage II dMMR/MSI-H colorectal cancer. The rational of giving PD-1 blockade as adjuvant therapy is based on the fact that tumor recurrence is extremely low among patients receiving neoadjuvant immunotherapy, which suggests that PD-1 blockade may likely improve patients' long-term survival. As for the short course (two cycles), we have the following considerations: firstly, the NICHE-2 trial, which adopted a two-cycle regimen, reported no recurrences during follow-up, suggesting that short-course anti-PD-1 therapy may be sufficient to improve the survival of patients with localized dMMR/MSI-H colorectal cancer. Secondly, the potential benefits of PD-1 blockade should be balanced against its toxicities, because patients with stage-II dMMR colorectal cancer generally have a good prognosis. Two cycles of PD-1 blockade have been shown to have a good safety profile, with low incidence of grade 3-4 and immune-related adverse events.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage II
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: chemotherapy
Cannot have received: immunotherapy
Cannot have received: biologic therapy
Cannot have received: targeted therapy
Cannot have received: radiation therapy
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06520683 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage II is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages