51
Participants
Start Date
November 13, 2020
Primary Completion Date
December 1, 2026
Study Completion Date
December 31, 2026
PD-1 antibody+ HDAC inhibitor
"Patients receive anti-PD-1 antibody Sintilimab+ HDAC inhibitor Chidamide three weeks for a cycle, detailed as follows:~* Anti-PD-1 antibody (Sintilimab): Fixed dose of 200 mg every 3 weeks, intravenous drip (without pretreatment), infusion time: 30 minutes (no less than 20 mins, no more than 60 mins), the maximum treatment period is 2 years (up to 35 doses), complete remission(CR)patients confirmed by imaging assessment can be considered off anti-PD-1 treatment after 12 treatment cycles.~* Chidamide: Chidamide is administered orally at a dose of 30mg (initial dose). It is recommended to be administered within 0.5h after a meal with a fixed time. Chidamide will be given until disease progression or intolerant toxicity. The maximum treatment is 2 years. If chidamide therapy requires to be continued over 2 years due to clinical benefit, the prescription/decision should be made after discussion with the principal investigator."
RECRUITING
Dongmei Ji, Shanghai
Fudan University
OTHER