Cervical CancerPhase 2NCT05557565
A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer
A Phase 2 study testing QL1706 in people with Cervical Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- QL1706
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2021to 30 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- The subject will participate voluntarily and sign the informed consent form.
- Female, aged ≥18 years when signing the informed consent form.
- Recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy.
- At least one measurable lesion is needed.
- The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
- Adequate reserves of organ function is needed.
Who cannot join
- Active autoimmune disease.
- Central nervous system (CNS) metastasis.
- Concomitant diseases such as cardiovascular and cerebrovascular diseases.
- Fistula of female genital tract.
- Diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment.
- Previous recipients of immune checkpoint inhibitors.
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- Received systemic antitumor drugs such as chemotherapy and targeted therapy within 4 weeks before the first use of the experimental drug; Received proprietary Chinese medicine with anti-tumor indications within 2 weeks before the first use of the experimental drug.
- Received radical concurrent chemoradiotherapy or adjuvant chemoradiotherapy within 12 weeks before the first use of the investigational drug; Received palliative radiotherapy (e.g., reductive radiotherapy for pain or bleeding) or other local treatments (e.g., radiofrequency ablation, transarterial chemoembolization, etc.) within 2 weeks before the first use of the investigational drug.
- History of immunodeficiency.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jihong Liu, Doctor, 13826299236, LiuJH@sysucc.org.cn
About this study
Official title: A Single-arm, Open, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Recurrent or Metastatic Cervical Cancer
This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.
Read the detailed description
This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer who have failed at least first-line platinum-containing standard therapy.
The study was divided into screening period/baseline, treatment period, and post-treatment follow-up period. Efficacy evaluation and safety monitoring should be performed throughout the study.
- Conditions
- Cervical Cancer
- Being tested
- QL1706
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| QL1706 injection | Experimental | The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion Receives: Drug: QL1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)
The ORR assessed by the Independent Image Review Board (IRC) according to RECIST V1.1
Measured: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
Secondary outcomes (4)
The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1
The ORR assessed by the investigator according to RECIST V1.1
Measured: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
The Disease Control Rate (DOR) assessed by the Independent Image Review Board (IRC) and the investigator
The DOR assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1
Measured: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
The Progression-free survival (PFS) assessed by the Independent Image Review Board (IRC) and the investigator
The PFS assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last QL1706 injection has been administered.
Overall survival
Overall survival
Measured: From date of enrollment until the date of death from any cause or date of lost to visit, assessed up to 2 years after the last QL1706 injection has been administered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start21 Dec 2021
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihong Liu, Doctor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557565
- Sponsor's protocol ID
- QL1706-206
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lou H, Zhou Y, Li D, Zhang H, Zhang M, Wang L, Cheng H, Liu Z, Duan W, Feng M, Zhang J, Chen L, Wang D, Yu J, Li C, Wang C, Wang P, Li H, Kang X, Liu J. Iparomlimab and tuvonralimab in previously treated patients with cervical cancer. Cell Rep Med. 2026 Aug 4:102944. doi: 10.1016/j.xcrm.2026.102944. Online ahead of print.
PubMed 42551432
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT05557565
- Acronym / sponsor ID
- QL1706-206
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 28 Sep 2022 (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.
This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.
Detailed description
This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer who have failed at least first-line platinum-containing standard therapy.
The study was divided into screening period/baseline, treatment period, and post-treatment follow-up period. Efficacy evaluation and safety monitoring should be performed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 injection | Experimental | Drug: QL1706The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject will participate voluntarily and sign the informed consent form.
- Female, aged ≥18 years when signing the informed consent form.
- Recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy.
- At least one measurable lesion is needed.
- The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
Key exclusion criteria (10 listed)
- Active autoimmune disease.
- Central nervous system (CNS) metastasis.
- Concomitant diseases such as cardiovascular and cerebrovascular diseases.
- Fistula of female genital tract.
- Diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1706The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion | Drug | QL1706 injection |
Primary outcome
The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)
Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
The ORR assessed by the Independent Image Review Board (IRC) according to RECIST V1.1
4 secondary outcomes
The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1
Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
The Disease Control Rate (DOR) assessed by the Independent Image Review Board (IRC) and the investigator
Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
The Progression-free survival (PFS) assessed by the Independent Image Review Board (IRC) and the investigator
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last QL1706 injection has been administered.
Overall survival
Time frame: From date of enrollment until the date of death from any cause or date of lost to visit, assessed up to 2 years after the last QL1706 injection has been administered.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 42551432Lou H, Zhou Y, Li D, Zhang H, Zhang M, Wang L, Cheng H, Liu Z, Duan W, Feng M, Zhang J, Chen L, Wang D, Yu J, Li C, Wang C, Wang P, Li H, Kang X, Liu J. Iparomlimab and tuvonralimab in previously treated patients with cervical cancer. Cell Rep Med. 2026 Aug 4:102944. doi: 10.1016/j.xcrm.2026.102944. Online ahead of print.
- 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. This study is not recruiting at the moment.
Jihong Liu, Doctor principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 in people with Cervical Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peizhen Wang, bachelor (18001246877, peizhen.wang@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC) (time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557565, which also lists 1 linked publication.
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 28 Sep 2022.