Cervical Cancer Stage IVBPhase 2QL1706NCT06882447
A Study of QL1706 Combined with Nine HPV Vaccine As First-line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer
A Phase 2 study testing Trial drug: QL1706, HPV 9-valent vaccine in people with Cervical Cancer Stage IVB, run by Northern Jiangsu People's Hospital.
Trial summary
The study medications were used as follows: 1 cycle every 21 days (3 weeks) of the following regimen. Test drug: QL1706, HPV 9-valent vaccine QL1706: Dose: 5 mg/kg ; intravenous infusion (ivgtt), administered on Day 1 of each cycle and every 3 weeks (21 days). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer Stage IVB
- What is being tested?
- Trial drug: QL1706, HPV 9-valent vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2028
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
- Patients with unsystematically treated cervical cancer, who voluntarily participate in the clinical study; fully understand and informed about the study and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all the trial procedures.
- With histologically confirmed diagnosis of cervical cancer, a pathology report and pathology slides are required.
- have at least one measurable lesion as assessed by the investigator according to RECIST 1.1. Note: Measurable target lesions cannot be selected from previous radiotherapy sites. If the target lesion at the site of prior radiotherapy is the only optional target lesion, the investigator is required to provide anterior and posterior imaging data showing significant progression of this lesion.
- Recovery of AE associated with prior antitumor therapy to CTCAE ≤ Grade 1 (except for Grade 2 alopecia).
- ECOG score ≤ 1 within 7 days prior to first dose of study drug.
- expected survival ≥ 12 weeks.
- Subjects with chronic HBV infection must have HBV-DNA < 1000 copies/ml and must agree to receive antiviral therapy according to treatment guidelines for patients with hepatitis B surface antigen positivity; patients with HCV-RNA positivity must agree to receive antiviral therapy according to treatment guidelines and have liver function at CTCAE ≤ grade 1.
- Normal major organ function, i.e., the following criteria are met (no transfusion, erythropoietin, or colony-stimulating factor (G-CSF) therapy within 14 days prior to administration of study drug) Hematologic Neutrophils (ANC) ≥ 1.5 x 109/L Platelets (PLT) ≥ 90×109/L Hemoglobin (Hb) ≥ 90g/L Liver Function Total bilirubin (TBIL) ≤ 1.5 x upper limit of normal (ULN) Glutamate aminotransferase (ALT) ≤ 2.5×ULN; For patients with liver metastases ≤ 5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN; For patients with liver metastases ≤ 5×ULN Renal Function Creatinine (Cr) ≤ 1.5×ULN; If > 1.5 x ULN, creatinine clearance ≥ 50 ml/min. (calculated according to the Cockcroft-Gault formula) Coagulation Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN Prothrombin time (PT) ≤ 1.5×ULN International normalized ratio (INR) ≤ 1.5×ULN
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study drug and be willing to use a hi ghly effective method of contraception for the duration of the trial and for 90 days after the last administration of the test drug.
About this study
Official title: A Prospective, Single-center, Single-arm, Phase II Study of QL1706 Combined with Nine价HPV Vaccine As First-line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer
The study medications were used as follows: 1 cycle every 21 days (3 weeks) of the following regimen.
Test drug: QL1706, HPV 9-valent vaccine
Read more
QL1706: Dose: 5 mg/kg ; intravenous infusion (ivgtt), administered on Day 1 of each cycle and every 3 weeks (21 days).
Treatment will continue until loss of clinical benefit, occurrence of intolerable toxicity, patient or physician decision to discontinue treatment, death of the patient receiving the experimental treatment, or completion of 2 years of dosing (35 dosing cycles), withdrawal of informed consent by the subject, pregnancy of the subject, noncompliance with protocol or procedural requirements, or for administrative reasons.
HPV 9-valent vaccine: 1st dose 1 day prior to first QL1706 administration; 2nd dose 2 months after 1st dose; 3rd dose 6 months after 1st dose.
- Conditions
- Cervical Cancer Stage IVB
- Being tested
- Trial drug: QL1706, HPV 9-valent vaccine
- 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.
Trial drug: QL1706, HPV 9-valent vaccineDrug
QL1706: Dose: 5 mg/kg ; intravenous infusion (ivgtt), administered on day 1 of each cycle and once every 3 weeks (21 days).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Other | Trial drug: QL1706, HPV 9-valent vaccine Receives: Drug: Trial drug: QL1706, HPV 9-valent vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
orr
Evaluating the objective remission rate (ORR) of QL1706 in combination with the nine-valent HPV vaccine for the first-line treatment of persistent, recurrent or metastatic cervical cancer
Measured: every 6 weeks (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Stage IVBStudies of the same condition, open and under way.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buhai Wang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882447
- Sponsor's protocol ID
- 2025ky030
- Acronym
- QL1706
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-arm, Phase II Study of QL1706 Combined with Nine价HPV Vaccine As First-line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT06882447
- Acronym / sponsor ID
- QL1706 / 2025ky030
- Conditions
- Cervical Cancer Stage IVB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Mar 2025 (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 study medications were used as follows: 1 cycle every 21 days (3 weeks) of the following regimen.
Test drug: QL1706, HPV 9-valent vaccine
QL1706: Dose: 5 mg/kg ; intravenous infusion (ivgtt), administered on Day 1 of each cycle and every 3 weeks (21 days).
Treatment will continue until loss of clinical benefit, occurrence of intolerable toxicity, patient or physician decision to discontinue treatment, death of the patient receiving the experimental treatment, or completion of 2 years of dosing (35 dosing cycles), withdrawal of informed consent by the subject, pregnancy of the subject, noncompliance with protocol or procedural requirements, or for administrative reasons.
HPV 9-valent vaccine: 1st dose 1 day prior to first QL1706 administration; 2nd dose 2 months after 1st dose; 3rd dose 6 months after 1st dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Other | Drug: Trial drug: QL1706, HPV 9-valent vaccineTrial drug: QL1706, HPV 9-valent vaccine |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Trial drug: QL1706, HPV 9-valent vaccineQL1706: Dose: 5 mg/kg ; intravenous infusion (ivgtt), administered on day 1 of each cycle and once every 3 weeks (21 days). | Drug | experimental group |
Primary outcome
orr
Time frame: every 6 weeks (±7 days)
Evaluating the objective remission rate (ORR) of QL1706 in combination with the nine-valent HPV vaccine for the first-line treatment of persistent, recurrent or metastatic cervical cancer
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 28 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trial drug: QL1706, HPV 9-valent vaccine in people with Cervical Cancer Stage IVB, run by Northern Jiangsu People's Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2025. 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.
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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
orr (time frame: every 6 weeks (±7 days)). 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 28 Mar 2025.