Actively Recruiting
Short-course PD-1 Blockade as Adjuvant Treatment for High-risk Stage-II DMMR/MSI-H Colorectal Cancer
Led by Sun Yat-sen University · Updated on 2024-11-07
180
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of two cycles of PD-1 blockade with Tislelizumab as adjuvant therapy compared to standard of care in patients with high-risk stage-II dMMR/MSI-H colorectal cancer. This phase III open-label trial aims to see if this approach can improve disease-free survival and overall survival, based on evidence that neoadjuvant immunotherapy reduces tumor recurrence and that short-course treatment may balance benefits with fewer side effects. Participants are randomly assigned to one of two groups. The experimental group receives Tislelizumab 200mg intravenously on day 1 and day 22, with or without adjuvant chemotherapy, while the control group receives standard of care, which may include surveillance alone or chemotherapy options like Capecitabine or CapeOx/FOLFOX. Routine follow-up visits occur every 3 months for the first 3 years and every 6 months during years 4 and 5. Throughout the study, participants undergo evaluations to measure disease-free survival over 3 years and overall survival over 5 years, along with monitoring adverse events up to 30 days after treatment ends. The study involves regular clinical assessments, imaging tests, and safety monitoring to track treatment effects. Enrollment is planned for 180 patients and follow-up extends over several years to assess long-term outcomes.
CONDITIONS
Brief Title
Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of dMMR and/or MSI-H colorectal carcinoma that has been surgically removed
- Pathologically confirmed stage II (T3-4,N0) colorectal cancer with at least one risk factor: T4 status, vascular invasion, perineural invasion, poor differentiation, or obstruction/perforation before surgery
- No signs of metastases on perioperative CT, MR, or PET-CT scans
- ECOG performance status of 0 or 1 within 10 days before study start
- Aged between 18 and 80 years
- No prior chemotherapy, immunotherapy, biologic or targeted therapy, or radiation for this cancer
- Adequate organ function
You will not qualify if you...
- Active autoimmune disease requiring systemic treatment within the past 2 years
- Positive surgical margin (R1/R2 resection)
- Post-operative complications preventing treatment
- Active infection needing systemic therapy
- Any other cancer within the past 5 years except certain low-risk skin or early-stage cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month
Participants receive two cycles of Tislelizumab 200mg intravenously on day 1 and day 22, with or without adjuvant chemotherapy after surgery, or standard of care treatment as determined by their doctor.
2 in-person visits for Tislelizumab infusions; adjuvant chemotherapy visits as per routine care
Duration - Up to 5 years
Participants undergo routine follow-up visits to monitor disease status and overall health.
Every 3 months for the first 3 years, then every 6 months for years 4 and 5
Trial Site Locations
Total: 1 location
1
Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
B
Bin-Yi Xiao, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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