This is a Phase Ib/II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With SHR6390 (a CDK4/6 Inhibitor) in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and Hepatocellular Carcinoma. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage. The first part of the study is the Dose-finding Phase designed to establish the safety of SHR-1210 Combination With SHR6390 at different dose Levels(150mg QD or 100mg QD ). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses . This study aims to evaluate the safety and efficacy of SHR-1210 combination with SHR6390 in the treatment of advanced CRC,NSCLC and HCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
SHR-1210 was administered 200mg iv every 2 weeks
SHR6390 was administered 150mg or 100mg oral daily with 3 weeks on and 1 week off
MTD /DLT (phase Ib)
Maximum Tolerated Dose/Dose Limiting Toxicity
Time frame: Within four weeks after dosing
ORR(phase II)
Overall Response Rate
Time frame: from the first drug administration up to two years
ORR(phase Ib)
Overall Response Rate
Time frame: from the first drug administration up to two years
Incidence of Treatment-Emergent Adverse Events (phase Ib/II)
adverse events/serious adverse events
Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose
CBR (phase Ib/II)
Clinical Benefit Rate
Time frame: from the first drug administration up to last patients treatment for 6 months.
DoR (phase Ib/II)
Duration of response
Time frame: from the first drug administration up to two years
PFS(phase Ib/II)
Progression-Free-Survival
Time frame: from the first drug administration up to two years
TTR(phase Ib/II)
Time to Response
Time frame: from the first drug administration up to one year
12m-OS
12 months Overall survival
Time frame: 12 months after the first drug administration
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