Not Yet RecruitingNot Applicable

TTE Study of QL1706 in Recurrent/Metastatic Cervical Cancer

280 participantsStarted 2026-06-15

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 system…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective response rate

Timeframe: From the date of first dose to achieving complete response or partial response, assessed up to 12 months

Trial details

NCT IDNCT07652983

SponsorQilu Hospital of Shandong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31

Contact for this trial

peng Li

+86 18560082010 peng_li2002@163.com

View on ClinicalTrials.gov More Recurrent or Metastatic Cervical Cancer trials