Trials / Unknown
UnknownNCT04958473
A Study of Sintilimab in Combination With Axitinib in Advanced Renal Cell Cancer
A Single-center, Non-randomized Controlled, Single-arm, Phase II Clinical Trial of Sintilimab in Combination With Axitinib in the Treatment of Advanced Renal Cell Carcinoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Tianjin Medical University Second Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In patients with recurrent or metastatic renal cell carcinoma, a preliminary evaluation of the safety and efficacy of sintilimab combined with axitinib in patients with advanced renal cell carcinoma was conducted.Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and disease remission rate (ORR) were evaluated.
Detailed description
Patients with recurrent or metastatic renal cell carcinoma received axitinib tablets (5mg bid po) combined with sintilimab (200mg d1) on a 3-week (21-day) as a one-cycle regimen.6 months of continuous administration (i.e., 8 cycles of sintilimab) or until tumor progression or unacceptable toxicity or death or subject withdraws informed consent;If the drug has been discontinued or the tumor has progressed, and there are no intolerable side effects, the drug can be continued according to the judgment of the researchers and the will of the subjects. Drug safety was evaluated before each cycle.The first efficacy was evaluated after 2 cycles.The efficacy was then evaluated every 2 cycles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sintilimab | PD-1 inhibitor，Sintilimab 200mg IV, every 3 weeks. |
| DRUG | Axitinib | Tyrosine kinase inhibitor，licensed for use in treatment of renal cell carcinoma. Oral treatment Axitinib given 5 mg PO BID. |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2022-08-01
- Completion
- 2025-08-01
- First posted
- 2021-07-12
- Last updated
- 2021-07-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04958473. Inclusion in this directory is not an endorsement.