Cervical Cancer
Conditions
Brief summary
Efficacy and safety of Tislelizumab combined with Bevacizumab and chemotherapy in patients with persistent, recurrent or metastatic cervical cancer.
Detailed description
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.
Interventions
DRUGTislelizumab / Bevacizumab/Paclitaxel/Cisplatin/Carboplatin
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.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntary participation and signature of informed consent; 2. Age ≥18; 3. Eastern United States Cancer Collaboration Group (ECOG) score 0-1; 4. Patients with metastatic (IVB), persistent or first recurrent cervical cancer is unsuitable for surgical treatment; 5. Histopathology was defined as: cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, patients included in adenocarcinoma histology will be limited to 20% of the entire study population; 6. Patients must have lesions that can be measured according to RECIST v1.1 criteria; 7. The main organs function well and are defined as: * Patients received no blood, platelet transfusion or growth factor support treatment within 14 days ≤ the beginning of treatment and was required to: * x 109/L ANC ≥1.5 * Platelet ≥100 x 109/L * g/L ≥90 * AST and ALT≤2.5 times ULN (5 times if liver metastasis occurs) * Serum total bilirubin ≤ ULN 1.5 times * Serum creatinine \<1.5x upper limit (ULN) * Urine routine examination, urine protein \<2+ * The internationally standardized ratio (INR)≤1.5 or prothrombin time ULN 1.5 times * The activated partial thromboplastin time (aPTT)≤1.5 times ULN time * Serum albumin ≥30 g/L 8. Life expectancy ≥3 months; 9. Pregnant women must agree to effective contraception ≥120 days during the study period and after the last drug administration, and the results of serum pregnancy tests were negative 7 days ≤ before the first drug administration;
Exclusion criteria
1. Patients whose bilateral hydronephrosis can not be alleviated by ureteral stent or percutaneous drainage; non-communicable cystitis CTCAE(5.0 Edition)≥ grade 2; 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mPFS | 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. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | Up to approximately 24 months | 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 |
| DOR | 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. | 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 |
| ORR | Up to approximately 24 months | 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 |
| Serious AE (SAE) | The time from the first dosing of the study drug until 90 days after last dose of study treatment (Up to approximately 27 months ) | 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. |
| Immune-related AE (irAE) | The time from the first dosing of the study drug until 90 days after last dose of study treatment (Up to approximately 27 months ) | 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 . |
| Adverse Event (AE) | The time from the first dosing of the study drug until 90 days after last dose of study treatment (Up to approximately 27 months ) | 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. |
Countries
China
Contacts
Primary Contactjianqing zhu, docter
Outcome results
None listed