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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | Pathological complete response rate | Within one month after the third cycle of therapy ended (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of conversion to low-risk cervical cancer after treatment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sun Yat-sen Memorial Hospital of the Sun Yat-sen University | Guangzhou | Guangdong | 537216 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35143424 | Background | 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. | |
| 20595451 | 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. |
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When the trial is over and the relevant data has been published.
With the consent of the corresponding authors.
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|
Objective remission rate
| Within one month after the third cycle of therapy ended (each cycle is 21 days) |
| OS | Overall survival | 5 years after the end of the last treatment |
| EFS | Event free survival | 5 years after the end of the last treatment |
| PFS | Progression free survival | 5 years after the end of the last treatment |
| AE | Adverse event | During (3 months) and after the treatment (up to 1 year) |
| SAE | Serious adverse event | During (3 months) and after the treatment (up to 1 year) |
| 13829114 | 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. |
| 11330939 | 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. |
| 34253208 | 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. |
| 32878770 | 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. |
| 29432076 | 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. |
| 24064973 | 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. |