TTE Study of QL1706 in Recurrent/Metastatic Cervical Cancer

Официальное название

Real-World Effectiveness and Safety of Iparomlimab and Tuvonralimab in Recurrent or Metastatic Cervical Cancer: A Target Trial Emulation Study

Обзор

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.

Первичные конечные точки

• Objective response rate [Срок оценки: From the date of first dose to achieving complete response or partial response, assessed up to 12 months]

Вторичные конечные точки (5)

• Progression-free survival [Срок оценки: 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]
• Disease control rate [Срок оценки: From the date of first documented evidence of CR or PR to the date of PD or death, assessed up to 12 months.]
• Time to treatment failure [Срок оценки: 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.]
• Overall survival [Срок оценки: From the date of first dose to the date of death due to any cause, assessed up to 12 months]
• adverse event [Срок оценки: From first dose to the later of 90 days after the last dose of QL1706]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07652983 · KYLL-202604-034-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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