Status and phase
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About
This is a Phase Ib/IIa, Open-label, Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in combination with AIN457 for patients with late stage MSS CRC who failed second-line and above treatment.
The main purpose of this study is to evaluate the safety, tolerability and RD of SHR-1210 combination with AIN457 as a treatment of MSS CRC.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects voluntarily participate in this study and sign informed consent;
Men or women aged 18-75 years;
Patients with advanced colorectal cancer who failed to receive second-line or more standard treatment confirmed by pathology A)At least one measurable lesion that meets the RECIST v1.1 criteria; B)Microsatellite stability (MSS) required;
ECOG score was 0 or 1;
Have a life expectancy of at least 12 weeks;
The functions of vital organs meet the following requirements:
A) Sufficient bone marrow reserve: neutrophil absolute count ≥ 1.5x109/l, platelet ≥ 90x109 / L, hemoglobin ≥ 9 g / dl; B) Liver: plasma albumin ≥ 2.8g/dl; bilirubin ≤ 1.5 times of upper limit of normal value (ULN); ALT and AST ≤ 2.5uln, if there is liver metastasis, ALT and AST ≤ 5xuln; C) Kidney: serum creatinine ≤ 1.5 times ULN; D) Heart: left ventricular ejection fraction (LVEF) ≥ 50%; E) Coagulation: prothrombin time (PT) < 1.5 times ULN, INR ≤ 1.5 times ULN, APTT ≤ 1.5 times ULN; F) TSH ≤ ULN (if abnormal, FT3 and FT4 levels should be examined at the same time, if FT3 and FT4 levels are normal, they can be included in the group;
Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment;
Patients can provide more than 8 pathological sections of previous and / or fresh tissue lesions;
Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visit and research, understand the research procedures and have signed the informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Yanqiao Zhang, PhD
Data sourced from clinicaltrials.gov
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