TTE Study of QL1706 in Recurrent/Metastatic Cervical Cancer
11. juni 2026 opdateret af: Qilu Hospital of Shandong University
Real-World Effectiveness and Safety of Iparomlimab and Tuvonralimab in Recurrent or Metastatic Cervical Cancer: A Target Trial Emulation Study
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Undersøgelsestype
Observationel
Tilmelding (Anslået)
280
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: peng Li
- Telefonnummer: +86 18560082010
- E-mail: peng_li2002@163.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Recurrent or Metastatic Cervical Cancer
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
QL1706-based therapy (with or without chemotherapy/bevacizumab)
|
|
investigator-selected chemotherapy (with or without bevacizumab)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Objective response rate
Tidsramme: From the date of first dose to achieving complete response or partial response, assessed up to 12 months
|
From the date of first dose to achieving complete response or partial response, assessed up to 12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Progression-free survival
Tidsramme: 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
|
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
Tidsramme: From the date of first documented evidence of CR or PR to the date of PD or death, assessed up to 12 months.
|
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
Tidsramme: 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.
|
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
Tidsramme: From the date of first dose to the date of death due to any cause, assessed up to 12 months
|
From the date of first dose to the date of death due to any cause, assessed up to 12 months
|
|
adverse event
Tidsramme: From first dose to the later of 90 days after the last dose of QL1706
|
From first dose to the later of 90 days after the last dose of QL1706
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. juni 2026
Primær færdiggørelse (Anslået)
31. december 2028
Studieafslutning (Anslået)
31. december 2029
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
11. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Patologiske processer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Sygdomsegenskaber
- Livmodersygdomme
- Kønssygdomme, kvindelige
- Genitale neoplasmer, kvindelige
- Livmoderhalssygdomme
- Uterine neoplasmer
- Patologiske tilstande, tegn og symptomer
- Tilbagevenden
- Uterine cervikale neoplasmer
Andre undersøgelses-id-numre
- KYLL-202604-034-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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