A Phase 2 interventional study of TQB2450 in Recurrent or Metastatic Cervical Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 2, Interventional, and Treatment
This is a study to evaluate the efficacy and safety of TQB2450 injection in the treatment of PD-L1 positive recurrent or metastatic cervical cancer.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TQB2450 1200mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Drug: TQB2450
TQB2450 1200mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Overall response rate (ORR) evaluated by Independent Review Committee (IRC)
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on IRC.
Time frame: up to 12 months
Overall response rate (ORR) evaluated by investigator
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.
Time frame: up to 12 months
Disease Control Rate (DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 12 months
Duration of response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 12 months
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 12 months
Overall survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 18 months
DOR rate (≥ 6 months)
The percentage of participants achieved complete or partial remission ≥ 6 months.
Time frame: up to 12 months
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.