TTE Study of QL1706 in Recurrent/Metastatic Cervical Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorQilu Hospital of Shandong University
About this trial
The goal of this observational study is to evaluate the effectiveness and safety of Iparomlimab and Tuvonralimab (QL1706)-based therapy in patients with recurrent or metastatic cervical cancer who have experienced disease progression after platinum-based treatment.
The main questions it aims to answer are:
* Does QL1706-based therapy improve clinical outcomes compared with investigator-selected chemotherapy in patients with recurrent or metastatic cervical cancer? * Does the addition of bevacizumab further improve treatment effectiveness? * Which patient subgroups are most likely to benefit from QL1706-based therapy? Participants receiving QL1706-based therapy or investigator-selected chemotherapy as part of routine clinical practice will be followed through real-world clinical data collection. Using a target trial emulation framework, the study will compare treatment effectiveness and safety between groups. Clinical characteristics, treatment outcomes, and adverse events will be collected for analysis. In addition, artificial intelligence-based models and multi-omics analyses will be used to identify predictive biomarkers and explore potential mechanisms of treatment response and resistance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants voluntarily agree to participate in the study and provide written informed consent.
Age ≥18 years at the time of signing the informed consent form.
Histologically confirmed recurrent or metastatic cervical cancer (FIGO 2018 stage IVB), including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
Disease progression or treatment failure following prior platinum-based chemotherapy.
Disqualifiers
Histological subtypes including sarcoma, small-cell carcinoma with neuroendocrine differentiation, or other non-epithelial malignancies.
History of severe hypersensitivity reaction (Grade ≥3) to Iparomlimab and Tuvonralimab (QL1706) and/or any of its excipients.
Known additional malignancy that has progressed or required active treatment within the past 3 years.
Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive therapy); history of non-infectious pneumonitis requiring steroid treatment, or current pneumonitis.
Trial population
Recurrent or Metastatic Cervical Cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
280 Participants
are grouped into 2 trial groupsGroup A: QL1706-based therapy (with or without chemotherapy/bevacizumab)
Group B: investigator-selected chemotherapy (with or without bevacizumab)
Trial outcomes
Primary outcomes
1
Objective response rate
Time frame
From the date of first dose to achieving complete response or partial response, assessed up to 12 monthsSecondary outcomes
1
Progression-free survival
Time frame
From the date of first dose to the date of first documented progression or death from any cause, whichever occurs first, assessed up to 12 months2
Disease control rate
Time frame
From the date of first documented evidence of CR or PR to the date of PD or death, assessed up to 12 months.3
Time to treatment failure
Time frame
From the date of first dose to the date of first documented progression or death from any cause, whichever occurs first, assessed up to 12 months.4
Overall survival
Time frame
From the date of first dose to the date of death due to any cause, assessed up to 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: