Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1.Age: 18 to 80 years old, male or female;
2.Patients with histologically or cytologically confirmed dMMR/MSI-H rectal adenocarcinoma, clinical stage II-III;
3.No prior systemic therapy, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy;
4.ECOG Performance Status (PS) score of 0-1;
Disqualifiers
1.Patients with a confirmed allergy to the investigational drug and/or its excipients;
2.Subjects who have received or are currently receiving additional chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
3.Patients with any active autoimmune disease or a history of autoimmune disease;
4.Patients with Lynch syndrome;
Trial population
Patients with stage II-III dMMR rectal cancer
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Three-year event-free survival
Three-year event-free survival (EFS) is a medical metric used in oncology to evaluate the duration over which patients with a particular cancer diagnosis remain free from any cancer-related events, such as disease progression, recurrence, or death from the cancer, within a three-year period following the initiation of treatment.
Time frame
2028.09Secondary outcomes
1
Pathological complete response，pCR
Pathological complete response (pCR) is a term used in oncology to describe the absence of any viable tumor cells in the resected tissue specimen following treatment, typically neoadjuvant therapy (such as chemotherapy, radiation therapy, or immunotherapy) prior to surgery.
Time frame
2026.09Sponsors and contacts
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Source ClinicalTrials.gov