TTE Study of QL1706 in Recurrent/Metastatic Cervical Cancer

June 11, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Recurrent or Metastatic Cervical Cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
QL1706-based therapy (with or without chemotherapy/bevacizumab)
investigator-selected chemotherapy (with or without bevacizumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
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.
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
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
From first dose to the later of 90 days after the last dose of QL1706

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202604-034-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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