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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov