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

Sponsor
Sun Yat-sen University
Study ID
NCT04974944
Phase
PHASE2
Status
Unknown

Conditions

  • Persistent Cervical Cancer
  • Recurrent Cervical Cancer
  • Stage IVB Cervical Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    IV injection
  • Apatinib — DRUG
    Oral
  • Paclitaxel — DRUG
    IV injection
  • Cisplatin — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion
  • Bevacizumab — DRUG
    IV infusion

Study Details

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.

Key Dates

Start date
Jul 30, 2021
Status verified
Sep 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab + Apatinib
    On Day 1 and Day 15 of each 28-day cycle, participants receive an intravenous (IV) infusion of camrelizumab 200 mg Plus an oral apatinib 250 mg once daily. Apatinib will be administered 250 mg once every other day when completing twice tumor assessement. All treatments are administered until disease progression or unacceptable toxicity.
  • Active Comparator: Paclitaxel + Cisplatin/Carboplatin + Bevacizumab
    On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH bevacizumab 15 mg/kg OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5, WITH bevacizumab 15 mg/kg). All treatments are administered until disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: up to 36 months ]

Central Contacts