Actively Recruiting
Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer: a Prospective, Multicentre, Single-arm Study
Led by Xijing Hospital · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the optimal number of cycles of PD-1 monotherapy needed to achieve a pathological complete response (pCR) in patients with stage II-III dMMR/MSI-H rectal cancer. The study aims to ensure effective treatment while comparing pathological response rates, side effects, and three-year event-free survival among different treatment durations. Participants will receive preoperative PD-1 antibody monotherapy and undergo reassessment every two cycles. If a clinical complete response (cCR) is observed, surgery will be performed. The study is a prospective, multicenter, single-arm observational trial assessing the effects of varying treatment cycles. During the study, participants will be closely monitored through regular assessments to track treatment response and adverse reactions. Researchers will evaluate pathological complete response rates and three-year event-free survival. The study expects to follow participants until September 2028, with ongoing observation of outcomes and safety.
CONDITIONS
Brief Title
Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, male or female
- Histologically or cytologically confirmed dMMR/MSI-H rectal adenocarcinoma, clinical stage II-III
- No prior systemic therapy such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy
- ECOG Performance Status score of 0 or 1
- Estimated life expectancy of at least 3 months
- Normal major organ function with specified laboratory values within set ranges
- Voluntary participation with signed informed consent and good compliance
- Physical status score (PS) of 2 or less
- Patients and families understand and agree to participate, providing written informed consent
You will not qualify if you...
- Allergy to the investigational drug or its components
- Previous or current additional chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Active or history of autoimmune disease
- Diagnosis of Lynch syndrome
- Poorly controlled heart conditions such as NYHA Class II or higher heart failure, unstable angina, or recent myocardial infarction
- Pregnant or breastfeeding women
- Acute infections requiring antibiotics
- Positive hepatitis B or C antibodies
- Positive HIV antibodies
- Other diseases affecting prognosis and survival as determined by the investigator
- Any other conditions deemed unsuitable for participation by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Trial Site Locations
Total: 1 location
1
Xijing hospital
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
J
Jipeng Li, Doctor
Y
Yihuan Qiao, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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