This an open-label,Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of SHR-1210 in combination with Apatinib or chemotherapy (FOLFOX4 or GEMOX regimen) in subjects with Advanced PLC.or BTC Participants with advanced PLC who failed or intolerable to prior systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC or BTC who have never received prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 or GEMOX regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
157
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
Subjects receive Apatinib orally every day with a dose escalation
Subjects receive FOLFOX4 treatment every 2 weeks
Subjects receive GEMOX treatment every 2 weeks
The Second Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
Hunan Cancer Hospital
Hunan, Changsha, China
Cancer Hospital of Henan province
Zhengzhou, Henan, China
81 Hospital Nanjing
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Jiangxi, Nanchang, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The Safety and Tolerability
The incidence of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03
Time frame: Up to approximately 4 years
Objective Response Rate (ORR)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by investigator: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to approximately 4 years
Duration of Response (DoR)
The time from the date of the first recorded objective tumor response (assessed as per RECIST V1.1) to the date of the first recorded objective tumor progression (assessed as per RECIST V1.1) or the date of death due to any cause, whichever occurs first, in subjects with a BOR of CR or PR.
Time frame: Up to approximately 4 years
Disease Control Rate (DCR)
The percentage of subjects with a BOR of CR, PR, and SD as per RECIST V1.1. BOR of CR or PR must be confirmed at least 4 weeks (28 days) after the initial assessment.
Time frame: Up to approximately 4 years
Time to Progression (TTP)
The time from the date of the first dose to the date of radiographic PD (assessed by the investigator as per RECIST V1.1).PD is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or significant progression of non-target lesions leading to discontinuation of therapy, or the appearance of new lesions.
Time frame: Up to approximately 4 years
Overall Survival
The time from the date of the first dose to death due to any cause. Overal Survial will be calculated based on Kaplan-Meier estimates
Time frame: Up to approximately 4 years
Time to Response (TTR)
The time from the date of the first dose to the date of the first recorded tumor response (assessed as per RECIST V1.1) in subjects with a BOR of CR or PR.
Time frame: Up to approximately 4 years
Progression-free Survival (PFS)
The time from the date of the first dose to the date of the first recorded tumor progression (assessed as per RECIST V1.1) or the date of death due to any cause, whichever occurs first.
Time frame: Up to approximately 4 years
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