NCT02774200

A One-arm Exploratory Clinical Research Program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma Patients.

A One-arm Exploratory Clinical Research Program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A one-arm exploratory clinical research program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma （mRCC） Patients.It's arm to evaluate the treatment of advanced metastatic renal cell carcinoma in patients with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), quality of life score (QoL) and safety.

Detailed description

Objective response rate (ORR), disease control rate (DCR) (according to RECIST 1.1 Standard Edition)，progression-free survival (PFS), overall survival (OS), quality of life (QoL).Evaluation once every 8 weeks, If the efficacy results of the evaluation are complete response (CR) or partial response (PR), confirmed imaging efficacy at 4 weeks after the initial assessment ， efficacy evaluation time window of ± 7 days.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib 500 mg, po, qd, continuous medication for a period of eight weeks.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-12-01
• Completion: 2017-06-01
• First posted: 2016-05-17
• Last updated: 2016-05-17