Clinical trial · Observational
TTE Study of QL1706 in Recurrent/Metastatic Cervical Cancer
Real-World Effectiveness and Safety of Iparomlimab and Tuvonralimab in Recurrent or Metastatic Cervical Cancer: A Target Trial Emulation Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- QL1706-based therapy (with or without chemotherapy/bevacizumab)
- label
- investigator-selected chemotherapy (with or without bevacizumab)
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- From the date of first dose to achieving complete response or partial response, assessed up to 12 months
Secondary outcomes (5)
- measure
- Progression-free survival
- timeFrame
- 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
- measure
- Disease control rate
- timeFrame
- From the date of first documented evidence of CR or PR to the date of PD or death, assessed up to 12 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * At least one measurable target lesion according to RECIST version 1.1, as assessed by CT or MRI. * Estimated life expectancy of at least 3 months. * Considered suitable by the investigator for antitumor treatment with Iparomlimab and Tuvonralimab (QL1706), either as monotherapy or in combination with other therapies, and with a planned treatment regimen including QL1706. Exclusion Criteria: * 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. * Active infection requiring systemic therapy. * Any other medical condition, laboratory abnormality, or circumstance that, in the investigator's judgment, would make the participant unsuitable for participation in this study.
References
Publications (0)
Data not yet available