Trials / Unknown
UnknownNCT04974944
First-line Treatment With Camrelizumab + Apatinib Versus Chemotherapy + Bevacizumab in Advanced Cervical Cancer
An Open-label, Phase 2 Randomized Trial of Camrelizumab (SHR1210) Plus Apatinib Versus Paclitaxel and Cisplatin/Carboplatin Plus Bevacizumab as a First-line Therapy in Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 172 (estimated)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Cervical cancer is the second-most common cancer in the world and is a leading cause of cancer death among women in developing countries. Cisplatin-based chemotherapy +/- bevacizumab have been recommended as the first-line treatment for patients who present with metastatic (e.g. stage IVB), persistent, or recurrent cervical cancer. However, patients in this setting are rarely curable. The immune checkpoint inhibitor (ICI) therapy, including cytotoxic T-lymphocyte antigen 4 (CTLA-4), programmed death-1 (PD-1), and programmed death-ligand 1 (PD-L1) inhibitors, has revolutionized the treatment of several cancers. The investigator previously reported the promising antitumor efficacy of camrelizumab (PD-1 inhibitor) combined with apatinib (VEGFR2 inhibitor) as second-line, or later, therapy in patients with advanced cervical cancer. This randomized study is to assess the efficacy and safety of first-line treatment with camrelizumab plus apatinib compared to the efficacy and safety of paclitaxel and cisplatin/carboplatin plus bevacizumab in patients with stage IVB, recurrent, or persistent cervical cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Camrelizumab | IV injection |
| DRUG | Apatinib | Oral |
| DRUG | Paclitaxel | IV injection |
| DRUG | Cisplatin | IV infusion |
| DRUG | Carboplatin | IV infusion |
| DRUG | Bevacizumab | IV infusion |
Timeline
- Start date
- 2021-07-30
- Primary completion
- 2023-12-01
- Completion
- 2024-12-01
- First posted
- 2021-07-23
- Last updated
- 2021-10-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04974944. Inclusion in this directory is not an endorsement.