NCT06520683 Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer
| NCT ID | NCT06520683 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2024-11-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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%.
Contact & Investigator
Pei-Rong Ding, M.D.
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT06520683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06520683 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT06520683 currently recruiting?
Yes, NCT06520683 is actively recruiting participants. Contact the research team at xiaoby@sysucc.org.cn for enrollment information.
Where is the NCT06520683 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06520683 clinical trial?
NCT06520683 is sponsored by Sun Yat-sen University. The principal investigator is Pei-Rong Ding, M.D. at Sun Yat-Sen University Cancer Center. The trial plans to enroll 180 participants.
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