Recurrent or Metastatic Cervical CancerNCT07652983
TTE Study of QL1706 in Recurrent/Metastatic Cervical Cancer
An observational study of Recurrent or Metastatic Cervical Cancer, run by Qilu Hospital of Shandong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent or Metastatic Cervical Cancer
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 31 Dec 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Recurrent or Metastatic Cervical Cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Keywords
- Recurrent or metastatic cervical cancer, Iparomlimab and Tuvonralimab
- Medical subject headings
- Recurrence, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| QL1706-based therapy (with or without chemotherapy/bevacizumab) | Not described | |
| investigator-selected chemotherapy (with or without bevacizumab) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: From the date of first dose to achieving complete response or partial response, assessed up to 12 months
Secondary outcomes (5)
Progression-free survival
Measured: 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
Measured: 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
Measured: 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
Measured: From the date of first dose to the date of death due to any cause, assessed up to 12 months
adverse event
Measured: From first dose to the later of 90 days after the last dose of QL1706
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Cervical CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652983
- Sponsor's protocol ID
- KYLL-202604-034-1
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness and Safety of Iparomlimab and Tuvonralimab in Recurrent or Metastatic Cervical Cancer: A Target Trial Emulation Study
- ClinicalTrials.gov ID
- NCT07652983
- Acronym / sponsor ID
- KYLL-202604-034-1
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Keywords
- Recurrent or metastatic cervical cancer, Iparomlimab and Tuvonralimab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706-based therapy (with or without chemotherapy/bevacizumab) | – | – |
| investigator-selected chemotherapy (with or without bevacizumab) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recurrent or Metastatic Cervical Cancer
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective response rate
Time frame: From the date of first dose to achieving complete response or partial response, assessed up to 12 months
5 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent or Metastatic Cervical Cancer, run by Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact peng Li (+86 18560082010, peng_li2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From the date of first dose to achieving complete response or partial response, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.