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Locally Advanced Cervical CarcinomaPhase 3NCT07613567

A Clinical Study of QL1706 Combined With Chemotherapy as Neoadjuvant Therapy for High-Risk Locally Advanced Cervical Cancer

A Phase 3 study testing standard EBRT+Brachytherapy, Cisplatin and Neoadjuvant chemoimmunotherapy in people with Locally Advanced Cervical Carcinoma, run by Fujian Cancer Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to compare the efficacy and safety of "neoadjuvant immunotherapy combined with chemotherapy followed by immunotherapy combined with radiotherapy during the radiotherapy period" versus "standard concurrent chemoradiotherapy" in locally advanced cervical cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Locally Advanced Cervical Carcinoma
What is being tested?
standard EBRT+Brachytherapy, Cisplatin and Neoadjuvant chemoimmunotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
486 participants
Where
1 siteChina
Study dates
1 Sep 2026to 31 Aug 2032
Phase
Phase 3
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Age: 18-75 years; 2) Histologically confirmed cervical squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma; 3) Locally advanced disease (Stage III-IVA per FIGO 2018 staging criteria, including IIIC1/IIIC2), confirmed by imaging evaluation; 4) ECOG performance status 0-1; 5) Expected to be able to complete external beam radiation therapy (EBRT) combined with brachytherapy; 6) No definite contraindications to radiotherapy; 7) Able to provide pathological specimens (≥18 qualified tissue slides) for biomarker testing; 8) No prior surgery, radiotherapy, chemotherapy, systemic therapy (including investigational drugs), or immunotherapy for cervical cancer; 9) At least one measurable lesion (per RECIST 1.1: ≥10 mm longest diameter for non-lymph node lesions on CT; ≥15 mm short axis for lymph node lesions on CT); 10) Expected survival ≥6 months; 11) Adequate major organ function. Hematology (without transfusion or blood products within 14 days): ANC ≥1.5×10⁹/L; platelets ≥80×10⁹/L; hemoglobin ≥9 g/dL. Biochemistry: total bilirubin <1.5×ULN; AST and ALT ≤2.5×ULN; serum creatinine ≤1.5×ULN, or creatinine clearance ≥40 mL/min (using the standard Cockcroft-Gault formula); 12) Participants have signed informed consent and agree to comply with follow-up; 13) Women of childbearing potential must agree to use effective contraception during the study and for at least 12 months after the last dose (postmenopausal women or women not of childbearing potential are exempt).

Who cannot join

  • 1) Diagnosed with other malignancies within 5 years prior to first dose, excluding radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, radically excised carcinoma in situ, and/or papillary thyroid carcinoma; 2) Histologically confirmed small cell (neuroendocrine) cervical carcinoma, cervical carcinosarcoma, or gastric-type cervical adenocarcinoma; 3) FIGO 2018 Stage IVB disease; 4) Prior total hysterectomy (defined as removal of the entire uterus) or planned hysterectomy as part of initial cervical cancer treatment; 5) Bilateral hydronephrosis, unless at least one side has been stented or resolved by nephrostomy, or considered mild and not clinically significant by the investigator; 6) Anatomical or tumor geometric contraindications to intracavitary brachytherapy or combined intracavitary and interstitial brachytherapy, or any other contraindications; 7) Live vaccine administration within 30 days prior to first dose of study treatment; 8) Systemic immunostimulatory agents, colony-stimulating factors, interferons, interleukins, or vaccine combinations within 6 weeks or 5 half-lives (whichever is shorter) prior to Day 1 of Cycle 1; 9) Prior treatment with anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agents, or agents targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137); 10) Systemic anti-cancer therapy within 4 weeks prior to randomization, including investigational drugs; 11) Currently participating in or previously participated in a study with an investigational drug; 12) Contraindications to cisplatin use; 13) Diagnosed with immunodeficiency or receiving chronic systemic corticosteroid therapy (>10 mg/day prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to first study treatment; 14) Hypersensitivity to any study drug; 15) Active autoimmune disease requiring systemic therapy within the past 2 years; 16) History of (non-infectious) pneumonitis/interstitial lung disease requiring corticosteroids, or current pneumonitis/interstitial lung disease; 17) Active infection requiring systemic treatment; 18) Known history of human immunodeficiency virus (HIV) infection; 19) Known history of hepatitis B or known active hepatitis C viral infection; 20) Any condition, treatment, laboratory abnormality, or other circumstance that may increase risk associated with study participation or administration of study treatment, or may interfere with interpretation of study results, and judged by the investigator or sponsor to render the participant unsuitable for this study; 21) Known psychiatric or substance abuse disorders that would interfere with the participant's ability to comply with study requirements; 22) Prior allogeneic tissue/solid organ transplantation; 23) Evidence of metastatic disease per RECIST 1.1, including lymph nodes in the inguinal region or above the level of the L1 vertebral body; 24) Women with pregnancy desire, pregnant women, or breastfeeding women.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Qin Xu, 13950419396, xuqin@fjmu.edu.cn

Other trials in China

About this study

Official title: A Randomized, Multicenter, Phase III Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer

This study aims to compare the efficacy and safety of "neoadjuvant immunotherapy combined with chemotherapy followed by immunotherapy combined with radiotherapy during the radiotherapy period" versus "standard concurrent chemoradiotherapy" in locally advanced cervical cancer.

Being tested
standard EBRT+Brachytherapy, Cisplatin, Neoadjuvant chemoimmunotherapy, Radiotherapy combined with immunotherapy, Immunomaintenance therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard EBRT+BrachytherapyRadiation

    EBRT: 45-50.4Gy, Brachytherapy: 6Gy ×5

  • CisplatinDrug

    Cisplatin 40mg/m2, qw×5

  • Neoadjuvant chemoimmunotherapyDrug

    Neoadjuvant phase: total of 2 cycles. Iparomlimab/Tuvonralimab 5mg/kg,D1,Q3W + albumin paclitaxel 90mg/m2, D1、8、15,Q3W+ Cisplatin 25mg/m2 or Carboplatin AUC = 1.5 , D1、8、15,Q3W

  • Radiotherapy combined with immunotherapyRadiation

    Following neoadjuvant therapy, patients will receive EBRT + QL1706. After EBRT completion, brachytherapy dose is 600 cGy × 3 fractions for patients with clinical complete response (CCR), and 600 cGy × 5 fractions for non-CCR patients.

  • Immunomaintenance therapyDrug

    Iparomlimab/Tuvonralimab (QL1706) 5 mg/kg,D1,Q3W. Will be administered for up to 2 years, until disease progression, or until unacceptable toxicity, whichever occurs first.

Study groups in NCT07613567
Study groupRoleWhat they receive
Standard concurrent chemoradiotherapy(CCRT)Active comparatorAccept standard concurrent chemoradiotherapy
Receives: Radiation: standard EBRT+Brachytherapy; Drug: Cisplatin
Neoadjuvant Therapy GroupExperimentalParticipants in the experimental arm will receive 2 cycles of QL1706 + paclitaxel (albumin-bound) + Cisplatin/Carboplatin. Following neoadjuvant therapy, patients will undergo EBRT + QL1706. After EBRT completion, patients with clinical complete response (CCR) will receive brachytherapy at a dose of 600 cGy × 3 fractions; patients without CCR will receive brachytherapy at a dose of 600 cGy × 5 fractions. Subsequent sequential QL1706 will be administered for up to 2 years, until disease progression, or unacceptable toxicity.
Receives: Drug: Neoadjuvant chemoimmunotherapy; Radiation: Radiotherapy combined with immunotherapy; Drug: Immunomaintenance therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival(PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 60 months

Secondary outcomes (10)
  1. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 60 months

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed investigator per RECIST 1.1

    Measured: Up to approximately 60 months

  3. Disease Control Rate (DCR)

    DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by investigator per RECIST 1.1

    Measured: Up to approximately 3 years

  4. Clinical Complete Response Rate, CCR

    Defined as the absence of measurable tumor lesions on clinical examination and imaging assessment, which may be adjunctively confirmed by necessary pathological examinations (such as cervical biopsy). CCR is primarily used to guide brachytherapy dose stratification and is not used as a criterion for PFS event determination.

    Measured: Up to approximately 6 months

  5. Duration of Response (DOR)

    Assessed by investigators

    Measured: Up to approximately 3 years

  6. Time to Response (TTR)

    Assessed by investigators

    Measured: Up to approximately 3 years

  7. Time to Progression (TTP)

    Assessed by investigators

    Measured: Up to approximately 3 years

  8. Quality of Life Assessed by Patient-Reported Outcome Questionnaires (QoL)

    Quality of life will be assessed using EORTC QLQ-C30, EORTC QLQ-CX24, and EQ-5D questionnaires.

    Measured: Up to approximately 3 years

  9. Incidence of brachytherapy dose reduction

    Defined as the proportion of participants who, after completion of external beam radiotherapy (EBRT) and originally planned to receive the standard brachytherapy dose regimen (5 fractions), achieved the predefined clinical complete response (CCR) criteria and, upon investigator assessment, actually received a reduced number of brachytherapy fractions (3 fractions).

    Measured: Up to approximately 6 months

  10. Percentage of Participants With Adverse Events (AEs)

    Number of participants with adverse events (AEs) according to CTCAE 5.0

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Aug 2032 (estimated)
  4. Study completion31 Aug 2032 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, controlled, multicenter, phase III clinical study. Enrolled participants will be randomly assigned in a 1:1 ratio to the neoadjuvant therapy group and the standard concurrent chemoradiotherapy group.
Masking
None (open label)
Enrolment
486 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07613567
Sponsor's protocol ID
QL-CC-QIBA-3078
Status last verified
May 2026
First submitted
22 May 2026
Last updated
29 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because of privacy protection and ethical restrictions. Deidentified aggregate results may be shared in publications.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing standard EBRT+Brachytherapy, Cisplatin and Neoadjuvant chemoimmunotherapy in people with Locally Advanced Cervical Carcinoma, run by Fujian Cancer Hospital 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 1 inclusion and 1 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 29 May 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Qin Xu (13950419396, xuqin@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival(PFS) (time frame: Up to approximately 60 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 29 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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