This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.
This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer who have failed at least first-line platinum-containing standard therapy. The study was divided into screening period/baseline, treatment period, and post-treatment follow-up period. Efficacy evaluation and safety monitoring should be performed throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)
The ORR assessed by the Independent Image Review Board (IRC) according to RECIST V1.1
Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1
The ORR assessed by the investigator according to RECIST V1.1
Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
The Disease Control Rate (DOR) assessed by the Independent Image Review Board (IRC) and the investigator
The DOR assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1
Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
The Progression-free survival (PFS) assessed by the Independent Image Review Board (IRC) and the investigator
The PFS assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last QL1706 injection has been administered.
Overall survival
Overall survival
Time frame: From date of enrollment until the date of death from any cause or date of lost to visit, assessed up to 2 years after the last QL1706 injection has been administered.
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