Immunotherapy Versus Chemotherapy as Adjuvant Therapy for Colon Cancer With MSI-H or POLE/ POLD1 Mutations
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This is a two-group, parallel, randomized, standard-control phase II study comparing the
safety and efficacy of immunotherapy versus standard chemotherapy in patients undergoing
T4NX/TXN+ colon cancer surgery with MSI-H or POLE/ POLD1 mutations.This study was conducted
in the Department of Gastroenterology, Tumor Hospital of Tianjin Medical University.
Patients with MSI-H or POLE/ POLD1 gene mutations confirmed by PCR sequencing or NGS
sequencing will be randomly assigned (2:1) to immunotherapy (experimental group) or standard
chemotherapy (control group) after signing informed consent. In this study, 30 patients will
be enrolled, 20 patients will receive immunotherapy and 10 patients will receive standard
chemotherapy.
In the immunotherapy group, the treatment regimen was Tirelizumab 200mg, intravenously
infused once every 3 weeks until the end of 12 months of treatment, with a total of 17
infused times. Patients enrolled in this group could enjoy the preferential policy of
purchasing 7 times and giving 10 times at their own expense.
The chemotherapy regimen of the standard chemotherapy group was XELOX regimen, oxaliplatin
130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner),
d1-14, every 21 days. The duration of treatment was determined according to the patient's
postoperative pathological stage (3 months for T4N0/ T1-3N1 and 6 months for T4N+/ T1-3N2).
Patients received regular and periodic reviews, with imaging evaluations every 3 months for
the first 2 years and every 6 months after 2 years. Safety will be evaluated by AE and
laboratory tests. After tumor recurrence or metastasis was first detected, tumor tissue
biopsies were taken again for NGS sequencing, and all patients were followed up every 3
months until death according to the plan.
Phase:
Phase 2
Details
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital