NCT07205497

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

Iparomlimab and Tuvonralimab (QL1706) Combined With Neoadjuvant Chemotherapy Followed by Type I Hysterectomy for Locally Advanced Cervical Cancer（QNACTH）: A Prospective, Single-Arm, Multicenter, Phase 2 Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoadjuvant Immunotherapy
• Locally Advanced Cervical Cancer

Interventions

Type	Name	Description
DRUG	QL1706+TC	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.

Timeline

• Start date: 2025-03-28
• Primary completion: 2027-03-30
• Completion: 2030-03-30
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

1 site across 1 country: China