TTE Study of QL1706 in Recurrent/Metastatic Cervical Cancer

N/ANot Yet RecruitingNCT07652983

Qilu Hospital of Shandong University280 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

280

Conditions

Recurrent or Metastatic Cervical Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Objective response rate

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

Secondary Outcomes

Progression-free survival

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From the date of first dose to the date of death due to any cause, assessed up to 12 months

adverse event

Time frame: From first dose to the later of 90 days after the last dose of QL1706