| Methods |
Study type: RCT, parallel assignment, phase II
Blinding: unclear, "double‐blind" stated in the title, but "none (open‐label)" in the description on CT.gov
Study dates: May 2011‐ May 2016 (actual study completion period)
Countries: multicentre
Cross‐over study: no
Status: completed (as of May 3, 2018) |
| Participants |
Estimated enrolment: N = 150
Risk groups: no information
Inclusion criteria:
participants with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery first‐line therapy or second‐line treatment (second‐line treatment e.g. chemotherapy or cytokine therapy as first‐line treatment failure or resistant participants) with measurable disease (using RECIST1.0 standard conventional CT scan ≥ 20 mm, spiral CT scan ≥ 10 mm, target lesion did not receive radiation therapy, cryotherapy) male or female, age ≥18 and ≤75 ECOG 0‐1 life expectancy ≥ 3 months participants received surgery, chemotherapy, radiation therapy, cytokines treatment caused the damage has been restored, the time interval ≥ 4 weeks, and the wound has completely healed normal major organ function signed and dated informed consent
Exclusion criteria:
previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, sorafenib) past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ participated in other clinical trials within four weeks a variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhoea and intestinal obstruction) known brain metastases, spinal cord compression, cancer, meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
Age, median (years, range): 18‐75
Sex (m/f, (%)): all sexes are eligible
More inclusion criteria on CT.gov. |
| Interventions |
Experimental arm: Famitinib (Famitinib 25 mg once daily orally)
Control arm: Sunitinib (Sunitinib 50 mg orally once daily) |
| Outcomes |
Primary outcome(s)
‐
Secondary outcome(s)
PFS (time frame: 3 years) OS (time frame: 3 years) QoL (time frame: 42‐day cycle visit until disease progression) number of participants with AEs (time frame: 3 years)
Relevant to this review but not to be assessed: TFST, SAE, number of participants who discontinued treatment due to an AE
Other outcomes (not relevant to this review): ORR, DCR, body vitals, laboratory parameters |
| Notes |
Funding sources: Jiangsu HengRui Medicine Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Previous therapy: may include participants in second‐line therapy (see inclusion criteria). Awaiting results to check whether results for treatment‐naive participants are reported separately. |
