This is a single arm, multi-center clinical trial. Target population is patients with Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma,aiming to evaluate the efficacy and safety of the combination therapy of Camrelizumab and famitinib . Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody, and famitinib is an orally bioavailable receptor tyrosine kinase (RTK) inhibitor.
This trial enrolled patients with advanced or metastatic pulmonary sarcomatoid carcinoma. Patients will receive camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST version 1.1. Key secondary endpoints were progression-free survival (PFS), overall survival (OS), duration of response, and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Patients received camrelizumab 200 mg every 3 weeks
Patients received Famitinib 20 mg once per day
The first Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
ACTIVE_NOT_RECRUITINGHenan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
Objective Response Rate (ORR)
Objective Response Rate using RECIST 1.1 criteria, Proportion of patients with CR and PR
Time frame: about 24 month
Progression-free Survival
Time from the date of first dose to first observation of progression (RECIST1.1) or date of death (from any cause)
Time frame: about 24 month
Overall Survival
Time from the date of first dose to death from any cause
Time frame: about 24 month
Duration of response
Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause.
Time frame: about 24 month
incidence, type and severity of adverse events
Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Time frame: From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)
Disease control rate
Disease control rate using RECIST 1.1 criteria, Proportion of patients with CR, PR and SD
Time frame: about 24 month
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Qian Chu
Wuhan, Hubei, China
RECRUITINGHubei Cancer Hospital
Wuhan, Hubei, China
RECRUITINGRenmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
RECRUITINGThe Second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGThe First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
ACTIVE_NOT_RECRUITING