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NCT07652983Toborzás még nem indult

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 17.

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Megfigyeléses
Résztvevők száma
280 (tervezett)
Első benyújtás
2026. jún. 11.
Kezdés
2026. jún. 15.
Elsődleges befejezés
2028. dec. 31.
Fő szponzor
Qilu Hospital of Shandong University
Betegségek
Méhnyakrák
NCT-szám
NCT07652983

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 280
  • 2026. jún. 15. és az elsődleges befejezés (2028. dec. 31.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • 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.

Laborértékek

  • Any other medical condition, laboratory abnormality, or circumstance that, in the investigator's judgment, would make the participant unsuitable for participation in this study.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 18 év – - · Nem: csak nők · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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