RecruitingPhase 3NCT06520683

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

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


Sponsor

Sun Yat-sen University

Enrollment

180 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether treatment with an immunotherapy drug (a PD-1 blocker) after surgery can prevent colorectal cancer from coming back in people with Stage II colon cancer that has a specific genetic feature called mismatch repair deficiency (dMMR) or microsatellite instability (MSI-H). **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with Stage II colorectal cancer (T3 or T4, no spread to lymph nodes) that is dMMR or MSI-H - You have had surgery to remove the cancer - Your cancer had at least one high-risk feature: T4 stage, vascular invasion, nerve invasion, poor differentiation, or blockage/perforation before surgery - You have not received any chemotherapy or radiation for this cancer - You are in good general health (ECOG 0 or 1) **You may NOT be eligible if...** - You have an active autoimmune disease that required treatment in the past 2 years - Cancer cells were found at the surgical margins (R1/R2 resection) - You have a serious post-surgical complication - You have another active malignancy - You have an active infection requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

\- Tislelizumab 200mg (day 1 and day 22), administered after surgery

DRUGAdjuvant chemotherapy

* Adjuvant therapy is not mandatory. * Optional adjuvant regimens include FOLFOX, CapeOX, 5-FU+LV, or Capecitabine.


Locations(1)

Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651

Guangzhou, Guangdong, China

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NCT06520683


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