Trials / Unknown
UnknownNCT03827837
Famitinib Plus Anti-PD1 Therapy for Advanced Urinary System Tumor, Advanced Gynecological Tumors
Famitinib Malate Plus Anti-PD1 Therapy (SHR-1210) in Advanced Renal Cell Carcinoma, Urothelial Carcinoma, Advanced Cervical Cancer, Relapse Ovarian Cancer, Endometrial Cancer: Multi-institutional, Open-label, Phase 2 Trial
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 265 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase II multi-chort, adaptive two-stage, open label, nonrandomized study. The aim of our study is to evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210(Camrelizumab) in combination with a small-molecule multikinase inhibitor Famitinib in subjects with advanced RCC/UC/CC/EC and recurrent OC. chort1: Renal Cell Carcinoma (RCC) chort2: Urothelial Carcinoma(UC) chort3: Ovarian Cancer (OC) chort4: Cervical Cancer (CC) chort5: Endometrial Cancer (EC)
Detailed description
Stage 1: Approximately 110 participants will be recruited, 22 participants per chort; Stage 2: Approximately 55 participants will be recruited, 11 participants per chort, if more than 7（including 7） patients reached ORR in every chort ; Approximately 155 participants will be recruited, 21 participants per chort, if 3 ≤ patients \<7 patients reached ORR in every chort.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SHR-1210 | SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody |
| DRUG | Famitinib | a small-molecule multikinase inhibitor |
Timeline
- Start date
- 2019-01-23
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2019-02-04
- Last updated
- 2022-07-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03827837. Inclusion in this directory is not an endorsement.