This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Sintilimab administered via intravenous infusion; Linperlisib administered orally.
Sun Yat-sen Universitiy Cancer Center
Guangzhou, Guangdong, China
RECRUITINGDLT
Dose-limiting toxicity
Time frame: Cycle 1 (21 days)
RP2D
Phase II Recommended Dose
Time frame: Cycle 1 (21 days)
Objective response rate (ORR)
To investigate the antitumor efficacy
Time frame: Up to 24 weeks
AE and SAE
Number of participants with adverse events (AE) and severe adverse events (SAE)
Time frame: Up to 24 weeks
2-year Progression-free survival(PFS)
To investigate the antitumor efficacy
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
2-year Overall survival(OS)
To investigate the antitumor efficacy
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.