This study used a single-arm, open phase II multicenter trial design. All eligible subjects received TQB2868 plus platinum-based chemotherapy with or without bevacizumab. A total of 39 subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
TQB2868 injection is an anti-programmed cell death protein 1 (PD-1)/ transforming growth factor-β (TGF-β) dual-function fusion protein.
Paclitaxel injection prevents depolymerization of microtubules, inhibits mitosis, and hinders normal cell division.
Cisplatin injection can inhibit the DNA replication process of cancer cells
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Investigator-assessed objective response rate (ORR)
The proportion of subjects who achieve a prespecified reduction in tumor volume and maintain the minimum time requirement, including complete response (CR) and partial response (PR).
Time frame: Baseline to CR or PR ,about 12 months
Progression free survival (PFS)
The time between the first dose of medication and disease progression (PD) or death before PD; If there was no PD or death before PD, the date of the last imaging assessment was used as the cutoff date.
Time frame: Baseline up to PD or death, about 24 months
Disease control rate (DCR)
The proportion of patients whose tumors shrink or remain stable for a certain period of time, including CR, PR, and stable disease (SD) cases.
Time frame: Baseline up to PD or death, about 24 months
Duration of response (DOR)
It refers to the time between the first assessment of the tumor as CR or PR to PD or death before PD in subjects with CR or PR; If subjects with CR or PR did not present with PD or die before PD, the date of the last imaging assessment was used as the cutoff date.
Time frame: Baseline up to PD or death, about 24 months
Overall survival (OS)
The time from the first treatment to death from any cause.
Time frame: Baseline up to die, about 36 months
PFS rate (≥6 months)
The proportion of patients alive and free of disease progression from the beginning of the first treatment to 6 months.
Time frame: Baseline up to PD or death, about 24 months
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Carboplatin injection acts directly on DNA, thus inhibiting the vigorous division of tumor cells.
Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF).
Adverse event rate
Occurrence of all adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TEAEs), and immune-related adverse events (IRaes).
Time frame: Baseline to the end of the study, about 2 years
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ -C30)
For questions 1 to 28, choose a number from 1 to 4, where 1 means no and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, where 1 means very poor and 7 means very good.
Time frame: Baseline to the end of the study, about 2 years
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ -CX24)
EORTC QLQ-CX24 is a questionnaire for measuring the quality of life of patients with cervical cancer. It has 24 items, including 3 multi-dimensional dimensions of symptoms, body image and sexual/vaginal function, and 6 single-dimensional dimensions of sexual activity, sexual enjoyment, sexual anxiety, lymphedema, menopausal symptoms and peripheral neuropathy. "None" to "very" were scored from 1 to 4, and the score was inversely proportional to the quality of life.
Time frame: Baseline to the end of the study, about 2 years
EuroQol 5 Dimensions (EQ-5D) Health questionnaire
EQ-5D is a simple health measure developed by the European Society for Quality of Life. The EQ-5D mainly consists of two parts: the EQ-5D description system and the EQ-5D Visual Analogue Scale (EQ-VAS). The EQ-5D description system describes the health status in five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. The EQ-VAS is to record the self-rated health status of the respondents. The scale is 0-100, with 0 being "worst imagined health" and 100 being "best imagined health."
Time frame: Baseline to the end of the study, about 2 years
PD-L1 and TGF-β expression
PD-1/TGF-β double antibody can increase Leukocyte differentiation antigen 8 (CD8+) T cells in the tumor, reduce immunosuppressive myeloid cells, and inhibit PD-1/PD-L1 pathway on the basis of targeting and neutralizing TGF-β in the tumor microenvironment, which can restore the activity of T cells, enhance the immune response, and more effectively improve the inhibition of tumor.
Time frame: At baseline
Human papillomavirus (HPV) expression
The relationship between human papillomavirus and cervical cancer is very close. Persistent infection of high-risk human papillomavirus is one of the high risk factors for cervical cancer.
Time frame: At baseline