QL1706 Plus Neoadjuvant Chemotherapy Followed by Type I Hysterectomy for Locally Advanced Cervica… (NCT07205497) | Clinical Trial Compass
Active — Not RecruitingPhase 2
QL1706 Plus Neoadjuvant Chemotherapy Followed by Type I Hysterectomy for Locally Advanced Cervical Cancer
China54 participantsStarted 2025-03-28
Plain-language 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. 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)?
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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pCR rate
Timeframe: Within one month after the third cycle of therapy ended (each cycle is 21 days)
Trial details
NCT IDNCT07205497
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
. 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.
Exclusion criteria
. 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;