Actively Recruiting
Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer
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
This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR/MSI-H rectal cancer. Participants will receive preoperative monotherapy with PD-1 antibodies, with regular reassessments every 2 cycles. Surgical intervention will be performed if clinical complete response (cCR) is achieved. Researchers will compare the pathological complete response rates, adverse reactions, and three-year event-free survival rates across different treatment cycles.
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
CONTACT
Y
Yihuan Qiao, Doctor
CONTACT
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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