Evaluate the safety and efficacy of PD-1 antibody Carilizumab combined with apatinib for the conversion therapy of unresectable stage III and IV dMMR gastric cancer.
This study is a prospective, open label, single center, phase II clinical trial aimed at evaluating the safety and efficacy of PD-1 antibody Carilizumab combined with apatinib for the conversion therapy of unresectable stage III and IV dMMR gastric cancer. The study participants were unresectable stage III and IV dMMR gastric cancer patients who had not undergone any anti-tumor treatment. The study aims to enroll 20 participants with a primary endpoint of 1-year disease progression free survival rate. participants who meet the inclusion criteria will receive treatment with both Carilizumab and Apatinib, repeated every 21 days. During the conversion therapy period, the researchers evaluate whether surgery can be performed after every 2 cycles of medication for the subjects. After evaluation by the researchers, the participants were deemed eligible for surgery. Apatinib was discontinued for one cycle and an additional course of Carilizumab was administered in preparation for surgery. The time between the last dose and surgery was 3-6 weeks, with a maximum of 6 weeks. Both surgical and non-surgical subjects will continue to receive treatment with the original regimen of Carilizumab combined with Apatinib after surgery until disease progression, recurrence, or death, for a maximum of 2 years. After the treatment is completed, a treatment end visit, a post treatment safety visit, and survival follow-up will be conducted. Participants who end the study due to non disease progression reasons will undergo imaging evaluation at the end of treatment (if no imaging evaluation has been received within 4 weeks before the end of treatment), and imaging evaluation will be conducted every 2 months after the end of treatment to assess the time of disease progression. After the completion of treatment, the participants will undergo a survival follow-up every 90 days to collect and record their survival status and subsequent anti-tumor treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
After every 2 cycles of meparticipants. Apatinib was discontinued for one cycle and an additional course of Carilizumab was administered in preparation for surgery. The time between the last dose and surgery was 3-6 weeks, with a maximum of 6 weeks. Both surgical and non-surgical participants will continue to receive treatment with the original regimen of Carilizumab combined with Apatinib after surgery until disease progression, recurrence, or death, for a maximum of 2 years.
Peking University third hospital
Beijing, China
RECRUITINGThe rate of 1-year PFS
The progression free survival (PFS) was defined as the time from the beginning of systematic anti-cancer therapy to disease progression or death from any cause
Time frame: From enrollment to the end of treatment at 1year"
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