Efficacy and safety of Tislelizumab combined with Bevacizumab and chemotherapy in patients with persistent, recurrent or metastatic cervical cancer.
The current standard treatment for persistent, metastatic and recurrent cervical cancer is platinum-based combination chemotherapy as its first-line treatment option. However, the current treatment plan still can not meet the clinical needs of cervical cancer treatment, most patients will progress about 6 months after first-line treatment. At present, there are many clinical research evidence to support the PD-1 antibody for the treatment of recurrent cervical cancer. Immunotherapy can restore the environment of immune support and promote vascular normalization, while anti-angiogenesis can not only normalize tumor vessels, but also block immunosuppressive signals through many ways, so the two mechanisms complement each other. Inhibition of these two pathways will bring better and more lasting clinical benefits to cervical cancer patients. This study explores the efficacy and safety of tirelizumab combined with bevacizumab and chemotherapy in patients with persistent, recurrent, or metastatic cervical cancer. combining with immune checkpoint inhibitors on the basis of standard treatment regimens has a more potent and durable antitumor ability mechanistically, no significant adverse reactions overlap between immunotherapy and existing standard regimens from a safety perspective, and multiple immune checkpoint combined with antiangiogenic studies confirm safety in cervical cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Tisleliumab 200mg, Bevacizumab 7.5mg/kg, Paclitaxel 175mg/m2, and Cisplatin 50mg/m2 (or Carboplatin AUC5) IV on day 1 of every 21-day cycle.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGmPFS
mPFS of Tislelizumab in combination with bevacizumab and chemotherapy in patients with persistent, relapsed, or metastatic cervical cancer was assessed by investigators according to RECIST v1.1
Time frame: The time from the first dosing of the study drug until the first objective recording of disease progression or death from any cause, whichever occurred first, up to approximately 24 months.
ORR
ORR of Tislelizumab in combination with bevacizumab and chemotherapy in patients with persistent, relapsed, or metastatic cervical cancer were assessed by investigators according to RECIST v 1.1
Time frame: Up to approximately 24 months
DCR
DCR of Tislelizumab in combination with bevacizumab and chemotherapy in patients with persistent, relapsed, or metastatic cervical cancer was assessed by investigators according to RECIST v1.1
Time frame: Up to approximately 24 months
DOR
DOR of Tislelizumab in combination with bevacizumab and chemotherapy in patients with persistent, relapsed, or metastatic cervical cancer were assessed by investigators according to RECIST v 1.1
Time frame: DOR: refers to the time from the beginning of the first assessment of a tumor as CR or PR to the first assessment of PD or death from any cause, up to 24 months.
Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Time frame: The time from the first dosing of the study drug until 90 days after last dose of study treatment (Up to approximately 27 months )
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Serious AE (SAE)
An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; h.) Is a new cancer (that is not a condition of the study) or i.) Is associated with an overdose. The number of participants who experience an SAE will be presented.
Time frame: The time from the first dosing of the study drug until 90 days after last dose of study treatment (Up to approximately 27 months )
Immune-related AE (irAE)
AEs associated with tislelizumab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of tislelizumab treatment .
Time frame: The time from the first dosing of the study drug until 90 days after last dose of study treatment (Up to approximately 27 months )