Subject Recruitment 

Clinical Research on Combination of CM082 and Everolimus for Advanced Kidney Cancer Treatment

[Subject Recruitment]Patients Suffering CCRCC (Clear Cell Renal Cell Carcinoma)

1.Trial Profile

CFDA Approval No.: 2013L00579/2013L00581

Trial Subject: Phase-II/III Clinical Study on Curative Effect and Security of Combination of CM082 and Everolimus for Kidney Cancer Treatment Based on Random, Double Blind Double Dummy, Parallel Controlling and Multi-center Evaluation

Indication: Kidney Cancer

Drug Name: CM082 Tablet & Everolimus 

Description of Trial Drugs: CM082 is a multi-targeted RTK inhibitor, as the dual inhibitor for VEGFR and PDGFR. 

Target Number of Subjects: 390 Cases

2.Patient Orientation 

The indications of this trial shall be CCRCC patients failed in VEGFR-TKI treatment. 

3.Major Recruitment Criteria 

1.Subjects shall be identified to suffer from CCRCC by pathology (histological/cytological examination);

2.Subjects shall fail in an anti-VEGFR TKI treatment (targeted treatment for at least 6 months, e.g. Sorafenib, Sunitinib, Pazopanib or Axitinib; with/without the application of cytokine therapy);

3.Subjects shall be aged 18-75 years old, with an expected TTL≥12 weeks;

4.Subjects shall be equipped with the competence of understanding and signing the informed consent form voluntarily. The ICF must be signed prior to any trial procedure. 

Any intended patients can contact with hospitals participating in the research. Your physician will provide you with detailed information of this research and confirm whether you are qualified for this research based on your own condition and examinations. 

4.Research Design

390 subjects suffering kidney cancer will be divided into three treatment groups at 1:1:1 proportion randomly: CM082+Everolimus combined treatment group (Experimental Group 1), CM082 single drug treatment group (Experimental Group 2) and Everolimus single drug treatment group (Control Group). MSKCC will be the stratification factor for dynamic and random grouping. 

5.Subject Benefits

Subjects can receive the treatment of CM082 tablets or Everolimus and relevant examinations free of charge. 

6.List of National Branch Centers

7.Application & Recommendation

Please recommend qualified subject candidates to us. Our staff will contact the candidate you have recommended within three working days. Please keep the mobile phones unblocked! 

Contact Person: Ms. Shu Tel: 021-507900731 E-mail: kananji@bettapharma.com