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Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Prospective Single-Arm Phase II Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Objectives: The primary endpoint is the pathological complete response (pCR) rate in the resected tissue following neoadjuvant treatment. Secondary endpoints include safety (treatment related adverse events), objective response rate (ORR), 3 years overall survival, 3 years disease free survival, and quality of life. Study Duration: Total participation time depends on treatment response and surgical scheduling, with an expected duration of approximately 9 to 12 months (including neoadjuvant treatment, surgery, and potential maintenance therapy).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 18 to 70 years.

• Histologically or cytologically confirmed cervical cancer, FIGO stage IB3 or IIA2.

• Imaging findings showing pelvic lymph node short-axis diameter \< 1.5 cm and para-aortic lymph node short-axis diameter \< 1.5 cm.

• Pathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.

• No prior anti-tumor therapy.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Jihong Liu, Ph.D.
liujih@sysucc.org.cn
+86 20 87341779
Backup
Yun Zhou, M.D.
zhouyun@sysucc.or.cn
+86 20 87343105
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 103
Treatments
Experimental: QL1706 + TP/TC Neoadjuvant Chemoimmunotherapy
Participants receive up to 4 cycles of neoadjuvant therapy (once every 3 weeks) with iparomlimab and tuvonralimab (QL1706 250 mg, IV) plus paclitaxel (150-175 mg/m², IV) and either cisplatin (70-75 mg/m², IV, split over 2 days) or carboplatin (AUC=5, IV). Treatment response is assessed after 2 cycles. For patients achieving tumor shrinkage, neoadjuvant therapy continues for 2 additional cycles followed by imaging. Patients achieving complete response (CR) undergo cervical conization plus sentinel lymph node biopsy (SLNB) or pelvic lymph node dissection (PLND). Those achieving partial response (PR) or non-optimal pathological response after surgery undergo radical hysterectomy/trachelectomy plus SLNB/PLND. Participants who achieve optimal pathological response (pCR or residual tumor depth ≤3 mm) after surgery receive QL1706 maintenance therapy for up to 8 cycles (once every 3 weeks). Patients who cannot tolerate surgery or have contraindications undergo radical radiotherapy.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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