drugset / Trial / NCT04974944

First-line Treatment With Camrelizumab + Apatinib Versus Chemotherapy + Bevacizumab in Advanced Cervical Cancer

NCT04974944 ↗

Phase 2 Unknown 172 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-07-30
Primary completion
2023-12
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Comparator Carboplatin Small molecule 5 unknown Intravenous
Comparator Cisplatin Other / unclassified 50 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Rivoceranib Small molecule 250 mg Oral

Indications