This is a prospective, single-arm, multicenter Phase II study evaluating the efficacy and safety of QL1706 combined with chemotherapy in patients with advanced recurrent or metastatic endometrial cancer who progressed after prior anti-PD-1/L1 therapy.
This prospective, single-arm, multicenter Phase II study evaluates the efficacy and safety of QL1706 plus physician's choice chemotherapy (with or without bevacizumab) in patients with advanced recurrent or metastatic endometrial cancer refractory to prior PD-1/L1 inhibitor therapy. The study consists of three phases: screening, treatment, and post-treatment follow-up, with continuous safety monitoring throughout. Eligible patients had confirmed disease progression following previous PD-1/L1 inhibitor treatment. Participants received QL1706 combined with physician's choice chemotherapy, with or without bevacizumab. All participants will undergo post-treatment safety monitoring and survival follow-up after treatment completion. For patients who discontinue treatment for reasons other than disease progression or death, additional tumor progression follow-up will be conducted post-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
* Drug: QL1706: 5 mg/kg IV every 3 weeks until progression, unacceptable toxicity, completion of 1 year of treatment, or meeting protocol-defined discontinuation criteria, whichever occurred first. * Drug: Chemotherapy: physician's choice chemotherapy for 3-6 cycles. * Drug: Bevacizumab (optional): 15 mg/kg IV every 3 weeks until progression, unacceptable toxicity, completion of 1 year of treatment, or meeting protocol-defined discontinuation criteria, whichever occurred first.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
RECRUITINGObjective response rate (ORR) - Investigator assessment
the objective response rate (ORR) of treatment with QL1706 combined with chemotherapy ± Bevacizumab, as assessed by the Investigator per RECIST v.1.1.
Time frame: Up to 5 years
Progression-Free Survival (PFS) - investigator assessment
the Progression-Free Survival (PFS) of treatment with QL1706 combined with chemotherapy ± Bevacizumab, as assessed by the Investigator per RECIST v.1.1.
Time frame: Up to 5 years
Overall survival (OS)
the overall survival (OS) of treatment with QL1706 combined with chemotherapy ± Bevacizumab, as assessed by the Investigator per RECIST v.1.1.
Time frame: Up to 5 years
Duration of response (DOR) - Investigator assessment
the duration of response (DOR) of treatment with QL1706 combined with chemotherapy ± Bevacizumab, as assessed by the Investigator per RECIST v.1.1.
Time frame: Up to 5 years
Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Time frame: Up to 5 years
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