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Neoadjuvant ImmunotherapyPhase 2QNACTHNCT07205497

QL1706 Plus Neoadjuvant Chemotherapy Followed by Type I Hysterectomy for Locally Advanced Cervical Cancer

A Phase 2 study testing QL1706+TC in people with Neoadjuvant Immunotherapy and Locally Advanced Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to determine the effectiveness of the combination therapy of Eparbrutinib (QL1706) with neoadjuvant chemotherapy followed by Type I hysterectomy in treating locally advanced cervical cancer. Additionally, it will assess the safety profile of this treatment regimen. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
QL1706+TC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
28 Mar 2025to 30 Mar 2030
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinically diagnosed with untreated cervical cancer at stages IB3, IIA2, and resectable IIIC1r (according to the FIGO standards of 2018; determined by two senior physicians or above through gynecological examination and imaging studies);
  • At baseline, there is at least one measurable tumor lesion according to the RECIST 1.1 criteria, with the size of the lesion primarily determined by magnetic resonance imaging;
  • Pathologically confirmed cervical cancer, including squamous cell carcinoma (all grades), common type adenocarcinoma (Silva classification types A or B, or differentiated grades G1 or G2), and adenosquamous carcinoma (differentiated grades G1 or G2);
  • Patients must be aged between 18 and 70 years inclusive;
  • ECOG performance status score of 0 or 1;
  • Laboratory tests: White blood cell count (WBC) ≥ 3.5 × 10^9/L, neutrophil count (NEU) ≥ 1.5 × 10^9/L, platelet count (PLT) ≥ 100 × 10^9/L, serum bilirubin ≤ 1.5 times the upper limit of normal, transaminases ≤ 1.5 times the upper limit of normal, blood urea nitrogen (BUN) and creatinine (Cr) within normal limits;
  • Capable of follow-up and good compliance;
  • Able to sign an informed consent form, including adherence to the requirements and restrictions listed in the informed consent and this protocol.

Who cannot join

  • Participants with active, known, or suspected autoimmune diseases, or a history of autoimmune diseases, except for the following conditions: vitiligo, alopecia, Graves' disease, psoriasis, or eczema that does not require systemic treatment within the last 2 years, asymptomatic hypothyroidism or requiring only a stable dose of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes requiring only a stable dose of insulin replacement therapy, asthma that has completely resolved in childhood and does not require intervention in adulthood, or diseases that do not relapse without external triggers;
  • Previously treated with immune checkpoint inhibitors, including but not limited to other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or any treatments targeting immune co-stimulatory factors (such as antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.) or other mechanisms of tumor immunotherapy;
  • Known allergic reactions to any components and/or excipients of the investigational medication;
  • Received immunosuppressive drugs or systemic corticosteroids for immunosuppression within 2 weeks prior to the study medication (more than 10mg/day of prednisone or other equivalent drugs), with the exception of local, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids;
  • Received traditional Chinese medicine with antitumor effects or drugs with immunomodulatory effects (such as thymic peptides, interferons, interleukin-2) within 2 weeks prior to the study;
  • Active systemic infections requiring systemic treatment;
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  • Experienced severe infections within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
  • Untreated chronic hepatitis B patients, or hepatitis B virus (HBV) carriers with HBV DNA greater than 1000 IU/mL, or patients with active hepatitis C. Non-active HBsAg carriers, treated and stable hepatitis B patients (HBV DNA < 1000 IU/mL), and cured hepatitis C patients are eligible. Subjects with positive HCV antibodies are only eligible if HCV RNA testing is negative;
  • Known active pulmonary tuberculosis (TB), suspected active TB patients should undergo chest X-ray and sputum tests, combined with clinical symptoms and signs to rule out;
  • Immunodeficiency or human immunodeficiency virus (HIV antibody positive);
  • Participants with active inflammatory bowel disease or a history of such diseases (such as Crohn's disease, ulcerative colitis, or chronic diarrhea). Participants who cannot swallow or have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal diseases that severely affect drug intake and absorption;
  • Known interstitial lung disease, symptomatic or likely to hinder the detection or treatment of immune-related pneumonia;
  • Received live vaccines or attenuated vaccines within 4 weeks prior to the first trial dose, with the exception of inactivated seasonal influenza vaccines;
  • Patients who have undergone allogeneic bone marrow transplantation or solid organ transplantation;
  • History of primary malignant tumors within the last 5 years;
  • Participants who have undergone major surgery (such as laparotomy, thoracotomy, organ resection, etc.) and severe trauma within 28 days prior to the first dose, with the exception of implantable infusion devices;
  • History of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;
  • Uncontrolled other comorbidities, symptoms, or medical history, including: ① Those with one of the following cardiovascular or cerebrovascular diseases or risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute/persistent myocardial ischemia, cerebrovascular accident, transient ischemic attack, or other clinically significant/requiring medication intervention arterial venous thrombosis, embolism, or cerebral ischemic events; symptoms of congestive heart failure within 6 months (New York Heart Association (NYHA) class III or above); ② History of clinically significant bleeding symptoms or obvious bleeding features within 1 month prior to the first dose, such as gastrointestinal bleeding, peptic ulcer bleeding, or vasculitis; ③ Clinical manifestations of active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction; ④ Those with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; ⑤ History of liver or kidney abnormalities or surgery;
  • Pregnant or nursing women; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;
  • Simultaneously participating in other interventional clinical trials, participation in observational and non-interventional clinical trials is allowed;
  • Any condition deemed by the investigator to pose a risk when receiving the study medication, or that would interfere with the safety evaluation of the study medication or the interpretation of the study results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Sun Yat-sen Memorial Hospital of the Sun Yat-sen University

    Guangzhou, Guangdong, 537216

Other trials in China

About this study

Official title: Iparomlimab and Tuvonralimab (QL1706) Combined With Neoadjuvant Chemotherapy Followed by Type I Hysterectomy for Locally Advanced Cervical Cancer（QNACTH）: A Prospective, Single-Arm, Multicenter, Phase 2 Trial

The goal of this clinical trial is to determine the effectiveness of the combination therapy of Eparbrutinib (QL1706) with neoadjuvant chemotherapy followed by Type I hysterectomy in treating locally advanced cervical cancer. Additionally, it will assess the safety profile of this treatment regimen. The main questions it aims to answer are:

  1. Does the combination of Eparbrutinib (QL1706) with neoadjuvant chemotherapy lead to a higher rate of complete pathological response (pCR) compared to chemotherapy alone?
  2. What are the medical complications and side effects experienced by participants during the treatment with Eparbrutinib (QL1706)?
Read more

Researchers will compare the outcomes of patients receiving Eparbrutinib (QL1706) combined with neoadjuvant chemotherapy to those receiving standard treatment to evaluate the effectiveness in treating locally advanced cervical cancer.

Participants will:

  1. Take Eparbrutinib (QL1706) alongside cisplatin and albumin-bound paclitaxel every three weeks for three cycles.
  2. If the lesion was reduced to less than or equal to 2cm, conectomy was performed; if the pathological results indicated no high-risk factors, total hysterectomy was performed, and QL1706+TC was treated after surgery. If the lesion is larger than 2cm, a type III hysterectomy is performed and adjuvant treatment is determined according to sedlis criteria after surgery.
  3. Visit the clinic regularly for checkups, tests, and assessments throughout the treatment period.
  4. Keep a diary of their symptoms, side effects, and any changes in their health status.

This study is designed to provide insights into the potential benefits of adding Eparbrutinib (QL1706) to the standard neoadjuvant chemotherapy regimen for locally advanced cervical cancer, which may lead to improved treatment outcomes and survival rates for patients.

Being tested
QL1706+TC

What participants receive

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

  • QL1706+TCDrug

    Participants will take eparbrutinib (QL1706) alongside cisplatin and albumin-bound paclitaxel (TC) every three weeks for three cycles. If the lesion was reduced to less than or equal to 2cm, conectomy was performed; if the pathological results indicated no high-risk factors, total hysterectomy was performed, and QL1706+TC was treated after surgery. If the lesion is larger than 2cm, a type III hysterectomy is performed and adjuvant treatment is determined according to sedlis criteria after surgery.

Study groups in NCT07205497
Study groupRoleWhat they receive
Eparbrutinib (QL1706) + cisplatin and albumin-bound paclitaxelExperimentalParticipants will take eparbrutinib (QL1706) alongside cisplatin and albumin-bound paclitaxel (TC) every three weeks for three cycles. If the lesion was reduced to less than or equal to 2cm, conectomy was performed; if the pathological results indicated no high-risk factors, total hysterectomy was performed, and QL1706+TC was treated after surgery. If the lesion is larger than 2cm, a type III hysterectomy is performed and adjuvant treatment is determined according to sedlis criteria after surgery.
Receives: Drug: QL1706+TC

What is being measured

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

  1. pCR rate

    Pathological complete response rate

    Measured: Within one month after the third cycle of therapy ended (each cycle is 21 days)

Secondary outcomes (7)

  1. Rate of conversion to low-risk cervical cancer after treatment

    Rate of conversion to low-risk cervical cancer after treatment

    Measured: Within one month after the third cycle of therapy ended (each cycle is 21 days)

  2. ORR

    Objective remission rate

    Measured: Within one month after the third cycle of therapy ended (each cycle is 21 days)

  3. OS

    Overall survival

    Measured: 5 years after the end of the last treatment

  4. EFS

    Event free survival

    Measured: 5 years after the end of the last treatment

  5. PFS

    Progression free survival

    Measured: 5 years after the end of the last treatment

  6. AE

    Adverse event

    Measured: During (3 months) and after the treatment (up to 1 year)

  7. SAE

    Serious adverse event

    Measured: During (3 months) and after the treatment (up to 1 year)

Timeline

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

  1. First posted3 Oct 2025
  2. Study start28 Mar 2025
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Mar 2030 (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
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07205497
Sponsor's protocol ID
SYSKY-2025-206-01
Acronym
QNACTH
Status last verified
Mar 2026
First submitted
1 Apr 2025
Last updated
15 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.

    PubMed 35143424

  • Park JY, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. Outcomes after radical hysterectomy according to tumor size divided by 2-cm interval in patients with early cervical cancer. Ann Oncol. 2011 Jan;22(1):59-67. doi: 10.1093/annonc/mdq321. Epub 2010 Jul 1.

    PubMed 20595451

  • GRAY LA, BARNES ML, LEE JJ. Carcinoma-in-situ and dysplasia of the cervix. Ann Surg. 1960 Jun;151(6):951-60. doi: 10.1097/00000658-196006000-00019. No abstract available.

    PubMed 13829114

  • Covens A, Rosen B, Murphy J, Laframboise S, DePetrillo AD, Lickrish G, Colgan T, Chapman W, Shaw P. Changes in the demographics and perioperative care of stage IA(2)/IB(1) cervical cancer over the past 16 years. Gynecol Oncol. 2001 May;81(2):133-7. doi: 10.1006/gyno.2001.6158.

    PubMed 11330939

  • Jing H, Xiuhong W, Ying Y, Zhenrong L, Xiyun C, Deping L, Changmei S, Qi W, Tao P, Yiyun P. Neoadjuvant chemotherapy combined with radical surgery for stage IB2/IIA2 cervical squamous cell carcinoma: a prospective, randomized controlled study of 35 patients. World J Surg Oncol. 2021 Jul 12;19(1):209. doi: 10.1186/s12957-021-02318-y.

    PubMed 34253208

  • Gadducci A, Cosio S. Neoadjuvant Chemotherapy in Locally Advanced Cervical Cancer: Review of the Literature and Perspectives of Clinical Research. Anticancer Res. 2020 Sep;40(9):4819-4828. doi: 10.21873/anticanres.14485.

    PubMed 32878770

  • Gupta S, Maheshwari A, Parab P, Mahantshetty U, Hawaldar R, Sastri Chopra S, Kerkar R, Engineer R, Tongaonkar H, Ghosh J, Gulia S, Kumar N, Shylasree TS, Gawade R, Kembhavi Y, Gaikar M, Menon S, Thakur M, Shrivastava S, Badwe R. Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Jun 1;36(16):1548-1555. doi: 10.1200/JCO.2017.75.9985. Epub 2018 Feb 12.

    PubMed 29432076

  • Nagano H. Comment on 'Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102)'. Br J Cancer. 2013 Oct 29;109(9):2505. doi: 10.1038/bjc.2013.581. Epub 2013 Sep 24. No abstract available.

    PubMed 24064973

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706+TC in people with Neoadjuvant Immunotherapy and Locally Advanced Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 8 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 15 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 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?

pCR rate (time frame: Within one month after the third cycle of therapy ended (each cycle is 21 days)). 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 NCT07205497, which also lists 8 linked publications.

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 15 May 2026.

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