TTE Study of QL1706 in Recurrent/Metastatic Cervical Cancer

NCT07652983 | Not Yet Recruiting

• 1 other identifier: KYLL-202604-034-1
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Recurrent or Metastatic Cervical Cancer

Keywords

Recurrent or metastatic cervical cancer; Iparomlimab and Tuvonralimab

Outcome Measures

Primary Outcomes (1)

• Objective response rate

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

Secondary Outcomes (5)

• Progression-free survival

  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

  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

  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

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

• adverse event

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

Study Arms (2)

QL1706-based therapy (with or without chemotherapy/bevacizumab)

investigator-selected chemotherapy (with or without bevacizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recurrent or Metastatic Cervical Cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Recurrence; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

peng Li

CONTACT

+86 18560082010; peng_li2002@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share