QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years and ≤70 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Recurrent or metastatic endometrial carcinoma, confirmed by pathology or imaging.
At least one measurable tumor lesion according to RECIST v1.1 criteria.
Disqualifiers
1. Previous treatment with PD-1/CTLA-4 dual-target immunotherapy, immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), or immune cell therapy.
Trial design
Design model
Single group
Treatments tested in this trial
QL1706 combined with chemotherapy ± Bevacizumab
Drug* 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: QL1706 Combination TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective 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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov