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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
The Sun Yat-sen Memorial Hospital of the Sun Yat-sen University
Guangzhou, Guangdong, China
pCR rate
Pathological complete response rate
Time frame: Within one month after the third cycle of therapy ended (each cycle is 21 days)
Rate of conversion to low-risk cervical cancer after treatment
Rate of conversion to low-risk cervical cancer after treatment
Time frame: Within one month after the third cycle of therapy ended (each cycle is 21 days)
ORR
Objective remission rate
Time frame: Within one month after the third cycle of therapy ended (each cycle is 21 days)
OS
Overall survival
Time frame: 5 years after the end of the last treatment
EFS
Event free survival
Time frame: 5 years after the end of the last treatment
PFS
Progression free survival
Time frame: 5 years after the end of the last treatment
AE
Adverse event
Time frame: During (3 months) and after the treatment (up to 1 year)
SAE
Serious adverse event
Time frame: During (3 months) and after the treatment (up to 1 year)
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