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AzTrials

Cervical Cancer Stage IVAPhase 2NCT07035808

a Single Arm, Phase II Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of Iparomlimab and Tuvonralima b and Chemotherapy ± Bevacizumab Induction Therapy Followed by Concurrent Chemoradiotherapy in Patients With Advanced Cervical Cancer .

A Phase 2 study testing 2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy in people with Cervical Cancer Stage IVA and Cervical Cancer Metastatic, run by Zhejiang Cancer Hospital.

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 is a single arm, phase II multicenter clinical trial to evaluate the efficacy and safety of the combination therapy of Iparomlimab and Tuvonralimab(QL1706) and chemotherapy ± bevacizumab induction therapy followed by concurrent chemoradiotherapy in patients with locally advanced cervical cancer at high risk… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
1 Jul 2025to 31 Dec 2029
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 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Sign a written informed consent before any trial-related procedures. 2. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
  • 3. Patients with stage Ⅳa confirmed by endoscopic biopsy and/or stage IB3-IIIC (FIGO 2018 staging) with large cervical tumors (maximum diameter ≥ 6 cm) and/or large lymph nodes (maximum short diameter of cross-section ≥ 2 cm) and/or ≥ 3 lymph node metastases confirmed by CT/MR/PET.
  • 4. Female patients aged ≥ 18 years and ≤ 75 years. 5. KPS ≥ 70. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • 7. Expected survival of more than 6 months. 8. No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy. 9. Major organ functions meet the following requirements: Absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 80×109/L, hemoglobin ≥ 80g/L; Total bilirubin level ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min; Serum albumin ≥ 28g/L; thyroid stimulating hormone (TSH) ≤ 1×ULN (if abnormal, FT3 and FT4 levels should also be examined. If FT3 and FT4 levels are normal, the subject can be enrolled).
  • 10. Subjects agree to use effective contraceptive measures from the time of signing the informed consent until 180 days after the last dose. Women of childbearing age must not be pregnant or lactating.
  • 11. All subjects must be willing to provide tumor tissue samples, blood samples, urine samples, fecal samples, and vaginal secretion samples after enrollment.

Who cannot join

  • Other histopathological findings such as neuroendocrine carcinoma, sarcoma, gastric-type adenocarcinoma, and malignant melanoma components;
  • Previous receipt of anti-tumor treatment related to cervical cancer;
  • Evidence of distant metastasis, including lymph node metastasis in the groin, supraclavicular, and axillary regions;
  • Previous total hysterectomy or subtotal hysterectomy;
  • Anatomical abnormalities or contraindications that preclude the use of brachytherapy;
  • Previous receipt of any treatment targeting tumor immune mechanisms, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies) or antibodies targeting immune co-stimulatory factors (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40 targets);
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  • Patients with other tumors that require current treatment;
  • Active or potentially recurrent autoimmune diseases, except for those that do not require systemic treatment: vitiligo, alopecia, psoriasis or eczema; hypothyroidism caused by autoimmune thyroiditis, requiring stable doses of hormone replacement therapy; type 1 diabetes requiring stable doses of insulin replacement therapy;
  • Patients currently using immunosuppressants or systemic hormones to achieve immunosuppression, and still using them within 2 weeks before enrollment;
  • Poorly controlled clinical symptoms or diseases of the heart, such as (1) NYHA grade 2 or above heart failure; (2) unstable angina pectoris; (3) severe myocardial infarction within 1 year; (4) need for treatment or intervention for clinically significant supraventricular or ventricular arrhythmias; (5) QTc > 450 ms (male), QTc > 470 ms (female);
  • Abnormal coagulation function (INR > 2.0, PT > 16s);
  • Known hereditary or acquired bleeding disorders or thrombophilia (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.);
  • Congenital or acquired immune deficiencies (such as HIV-infected individuals);
  • Patients with HBV DNA > 2000 IU/ml, or HCV RNA > 103, or HBsAg + anti-HCV antibody positive;
  • Active infections that require treatment or use of systemic anti-infective drugs within one week before the first administration;
  • Within 4 weeks before the first administration, received major surgical treatment or had significant trauma or required elective major surgical treatment during the study period.
  • Hypertension, and unable to achieve good control with antihypertensive drugs (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg); previous occurrence of hypertensive crisis or hypertensive encephalopathy;
  • Known that the patient was previously allergic to large molecule protein preparations. Has contraindications and allergies to epalorlimovalovirumab, cisplatin, carboplatin, paclitaxel, bevacizumab, any components thereof;
  • Presence of abnormal results that may interfere with the test results, prevent the subject from fully participating in the study, or laboratory abnormalities that the investigator considers not in the best interests of the subject.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hanmei Lou, chief physician contact

086-13666698395

zjszlyy@zjcc.org.cn

About this study

Official title: Efficacy and Safety of Iparomlimab and Tuvonralimab(QL1706) Combined With Chemotherapy ± Bevacizumab Induction Therapy Followed by Concurrent Chemoradiotherapy for High-risk Locally Advanced Cervical Cancer：a Single Arm, Phase II Multicenter Clinical Study

This study is a single arm, phase II multicenter clinical trial to evaluate the efficacy and safety of the combination therapy of Iparomlimab and Tuvonralimab(QL1706) and chemotherapy ± bevacizumab induction therapy followed by concurrent chemoradiotherapy in patients with locally advanced cervical cancer at high risk of IVA stage and/or giant cervical tumors and/or giant metastatic lymph nodes and/or multiple metastatic lymph nodes.

The enrolled patients first receive 2 cycles of combined drug induction therapy: paclitaxel+cisplatin/carboplatin ± bevacizumab+QL1706, every 3 weeks for 2 cycles; After induction therapy, synchronous radiotherapy and chemotherapy combined with immunotherapy: extracorporeal irradiation+post loading radiotherapy+synchronous chemotherapy+immunotherapy. During radiotherapy, single agent cisplatin/carboplatin treatment for 5 courses per week+QL1706 treatment every 3 weeks for 3 courses; After the end of radiotherapy and chemotherapy, immune maintenance therapy will be administered for six months: treatment with QL1706 every 3 weeks for 9 courses, followed by a follow-up period until the end of radiotherapy for 2 years or death.

Being tested
2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy
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.

  • 2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapyCombination product

    The enrolled patients first receive 2 cycles of combined drug induction therapy: paclitaxel+cisplatin/carboplatin ± bevacizumab+QL1706, every 3 weeks for 2 cycles; After induction therapy, synchronous radiotherapy and chemotherapy combined with immunotherapy: extracorporeal irradiation+post loading radiotherapy+synchronous chemotherapy+immunotherapy. During radiotherapy, single agent cisplatin/carboplatin treatment for 5 courses per week+QL1706 treatment every 3 weeks for 3 courses; After the end of radiotherapy and chemotherapy, immune maintenance therapy will be administered for six months: treatment with QL1706 every 3 weeks for 9 courses, followed by a follow-up period until the end of radiotherapy for 2 years or death.

Study groups in NCT07035808
Study groupRoleWhat they receive
treatment groupExperimentalNot described
Receives: Combination Product: 2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy

What is being measured

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

  1. 2-year PFS

    2-year PFS rate evaluated by researchers based on RECIST v1.1 and biopsy pathology

    Measured: 2 year

Secondary outcomes (3)

  1. ORR

    ORR of drug-induced therapy evaluated by researchers based on RECIST v1.1 and biopsy pathology

    Measured: 2 year

  2. DCR

    DCR of drug-induced therapy evaluated by researchers based on RECIST v1.1 and biopsy pathology

    Measured: 2 year

  3. OS

    2-year OS

    Measured: 2 year

Timeline

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

  1. First posted25 Jun 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035808
Sponsor's protocol ID
QL1706-2025-086
Status last verified
May 2025
First submitted
17 Jun 2025
Last updated
25 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy in people with Cervical Cancer Stage IVA and Cervical Cancer Metastatic, run by Zhejiang Cancer Hospital.

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 19 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 25 Jun 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?

Contact Hanmei Lou, chief physician (086-13666698395, zjszlyy@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year PFS (time frame: 2 year). 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 NCT07035808.

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 25 Jun 2025.

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