Efficacy and Safety of Bevacizumab Plus Sorafenib for the Third-line Treatment in Metastatic Renal Cancer Patients

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with Metastatic renal cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital
• Treatments: Bevacizumab; Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Age≥18 years, ≤75 years, male or female

• Advanced renal cellcarcinoma is diagnosed histologically or pathologically

• 1st line treatment of Sunitinib and 2nd line treatment of Everolimus and no more systemic anti-angiogenesis targeted drug therapy

• Have at least one measurable tumor lesion (Response Evaluation Criteria In Solid Tumors)

• Eastern Cooperative Oncology Group（ECOG) performance scale is 0 or 1

• The expected life span is ≥12 weeks

• No contraindications for chemotherapy, with enough liver function and renal function and normal ECG recording Peripheral hemogram: neutrophil≥1.5×109/L, Plt≥100×109/L, Hgb≥90g/L Renal function: serum creatinine≤1.5 folds the upper limit of normal (ULN) For patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 ULN, For patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 ULN

• The patients participate voluntarily and have signed the informed consent form

Exclusion Criteria:

• Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures

• Patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds

• Past history of serious heart diseases, including: cardiac function classification ≥NYHA class II, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension

• Patients with a history of HIV infection or active phase of chronic hepatitis B/C

• negative imaging examination result 4 weeks prior to enrollment)

• Epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs)

• A history of allogeneic organ transplantation

• Patients with evidence of hemorrhagic constitution or a past history of hemorrhage

• Patients currently receiving renal dialysis

• Past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment

• Patients participating in other clinical trials simultaneously

• Other conditions unsatisfying the inclusion criteria in the investigator's opinions