This is a Phase 2 clinical trial evaluating the efficacy and safety of sintilimab in subjects
Up to 45 subjects with CUP will be enrolled. Subjects will be treated with sintilimab at 200
mg via intravenous (IV) administration on Cycle 1 Day 1. The treatment will repeat every 3
weeks until progressive disease (PD), intolerable toxicity, initiation of new anti-tumor
therapy, withdrawal of consent, lost to follow-up, death, completion of therapy, or any other
investigator-determined reasons for treatment discontinuation (whichever occurs first).
Treatment will continue for a maximum period of 24 months (starting from the first dose).
During the trial, tumor imaging evaluation will be initially performed once every 9 weeks (
7 days) and will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. After
the completion or discontinuation of the study treatment, safety follow-up and survival
follow-up will be performed.
Considering the rareness of the disease, the patient accrual rate is expected to be
approximately 2 patients per month. The total study duration is expected to be between 24-27
months with 6-month follow up.
To evaluate the safety and efficacy of sintilimab in subjects with CUP
To evaluate the overall objective response rate (ORR) (investigator assessed), disease
control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall
survival (OS) and Quality of Life (QOL) on sintilimab in subjects with CUP
To evaluate the correlation between biomarkers in tumor tissue and efficacy, including
but not restricted to PD-L1 expression level, transcriptome sequencing, single-cell
sequencing, and multicolor immunohistochemistry (IHC) analyses;
To evaluate the correlation between biomarkers in peripheral blood and drug efficacy,
including but not restricted to soluble PD-L1, circulating tumor DNA (ctDNA), and
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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