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
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best number of PD-1 antibody treatment cycles needed before surgery for patients with stage II-III rectal cancer that has specific genetic characteristics called dMMR/MSI-H. The goal is to find the minimum treatment duration that still achieves a complete pathological response, meaning no cancer is found in tissue samples after treatment. This study will also assess side effects and compare survival without cancer events over three years. Participants will receive PD-1 antibody monotherapy before surgery, with evaluations every two treatment cycles to check their response. If a clinical complete response is reached, surgery will be performed. The study is designed as a prospective, multicenter, single-arm trial focusing on different lengths of neoadjuvant PD-1 therapy. During the study, participants will be regularly monitored for treatment response and side effects. Researchers will collect data on pathological response rates, adverse reactions, and three-year event-free survival. Participants must comply with follow-up visits and provide informed consent. The total study duration includes treatment cycles followed by surgery and long-term monitoring of outcomes.
CONDITIONS
Official 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, any gender
- 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 to 1
- Estimated life expectancy of at least 3 months
- Normal major organ function with no severe abnormalities in blood, heart, lungs, liver, kidneys, bone marrow, or immune system
- Laboratory tests meeting specified thresholds for hemoglobin, white blood cells, neutrophils, platelets, liver function, renal function, urine protein, occult blood, and fecal occult blood
- Voluntary participation with informed consent and good compliance
- Investigator believes patient can benefit from treatment; physical status score 2 or less
- Patients and families understand and agree to participate with written informed consent
You will not qualify if you...
- Allergy to the investigational drug or its ingredients
- Previous or current treatment with additional chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Any 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 within one year
- Pregnant or lactating women
- Acute infections requiring antibiotics
- Positive hepatitis B or C antibodies
- Positive HIV antibodies
- Other diseases that may affect prognosis and survival as judged by the investigator
- Any other conditions deemed unsuitable for study participation by the investigator
AI-Screening
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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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