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

NCT07205497 | Active Not Recruiting Phase 2

• 1 other identifier: SYSKY-2025-206-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are:

1. 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. 2.What are the medical complications and side effects experienced by participants during the treatment with Eparbrutinib (QL1706)?
3. 3.Take Eparbrutinib (QL1706) alongside cisplatin and albumin-bound paclitaxel every three weeks for three cycles.
4. 4.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.
5. 5.Visit the clinic regularly for checkups, tests, and assessments throughout the treatment period.
6. 6.Keep a diary of their symptoms, side effects, and any changes in their health status.

Conditions

Neoadjuvant Immunotherapy; Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• pCR rate

  Pathological complete response rate

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

Secondary Outcomes (7)

• Rate of conversion to low-risk cervical cancer after treatment

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

• ORR

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

• OS

  5 years after the end of the last treatment

• EFS

  5 years after the end of the last treatment

• PFS

  5 years after the end of the last treatment

Study Arms (1)

Eparbrutinib (QL1706) + cisplatin and albumin-bound paclitaxel

EXPERIMENTAL

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.

Drug: QL1706+TC

Interventions

QL1706+TC DRUG

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.

Eparbrutinib (QL1706) + cisplatin and albumin-bound paclitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 537216, China

Location

Related Publications (8)

• 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.

  PMID: 35143424 BACKGROUND

• 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.

  PMID: 20595451 BACKGROUND

• 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.

  PMID: 13829114 BACKGROUND

• 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.

  PMID: 11330939 BACKGROUND

• 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.

  PMID: 34253208 BACKGROUND

• 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.

  PMID: 32878770 BACKGROUND

• 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.

  PMID: 29432076 BACKGROUND

• 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.

  PMID: 24064973 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: October 3, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2030
• Last Updated: October 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When the trial is over and the relevant data has been published.
• Access Criteria: With the consent of the corresponding authors.

Locations

CN (1)