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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
IV injection
Oral
IV injection
IV infusion
IV infusion
IV infusion
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-Free Survival (PFS)
PFS defined as the time from randomization to the first documented disease progression per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: up to 36 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a complete response or a partial response per RECIST 1.1.
Time frame: up to 24 months
Duration of Response (DOR)
DOR is defined as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
Time frame: up to 24 months
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have CR, PR, and stable disease (SD).
Time frame: up to 24 months
Overall Survival (OS)
OS is defined as the time from the treatment to death due to any cause.
Time frame: up to 48 months
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: up to 48 months
Patient-reported outcomes (PROs)
PROs assessed by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI). The Functional Assessment of Cancer Therapy-General (FACT-G) is a 27-item self-report quality of life (QOL) measure that includes 4 subscales (physical well-being, social well-being, functional well-being and emotional well-being). The Trial Outcome of Index of FACT-Cx (FACT-Cx TOI) consists of two subscales from the FACT-G: Physical Well Being (7 items) and Functional Well Being (7 items), plus the Cervix Cancer-specific subscale (15 items). The total score is ranged 0-116 for FACT-Cx TOI. A higher score indicates better HRQL.
Time frame: up to 48 months
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