This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
The primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile.
Additionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H/dMMR status, and vaginal microbiota before and after treatment.
Female patients aged 18-65 years.
Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
FIGO 2018 stage IB1, IB2, or IB3 cervical cancer.
Pelvic MRI completed before enrollment.
Presence of uncontrolled concomitant malignancies.
Active autoimmune disease or history of autoimmune disease with potential recurrence.
Interstitial lung disease or uncontrolled pneumonitis.
Active hepatitis B or hepatitis C infection.
Single group
QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy
DrugQL1706 is a bifunctional PD-1/CTLA-4 antibody combination consisting of iparomlimab and tuvonralimab. Drug: Cisplatin Cisplatin administered as part of neoadjuvant chemotherapy. Drug: Paclitaxel Paclitaxel administered as part of neoadjuvant chemotherapy.
Pathological Complete Response (pCR)
Proportion of patients achieving pathological complete response after neoadjuvant therapy.
Objective Response Rate (ORR)
Proportion of patients achieving complete or partial response according to RECIST v1.1.
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression or death.
3-Year Pelvic Recurrence Rate
Proportion of patients with pelvic recurrence within 3 years.
Adverse Events
Incidence and severity of adverse events graded according to CTCAE v5.0.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
