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

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.

Timeline

Start

2025-03-28

Primary completion

2027-03-30

Completion

2030-03-30

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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