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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651
RECRUITING
Guangzhou
Contact Information
Primary
Bin-Yi Xiao, M.D.
xiaoby@sysucc.org.cn
+8615800004780
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2030-11-01
Participants
Target number of participants: 180
Treatments
Experimental: Tislelizumab Arm
Two cycles of Tislelizumab 200mg intravenously, on day 1 and day 22, with or without adjuvant chemotherapy
Active_comparator: Control Arm
Receiving standard of Care (either with adjuvant chemotherapy or surveillance alone).
Related Therapeutic Areas
Sponsors
Collaborators: BeiGene
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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