A Phase II, Single-Arm Study of QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy Prior to Conservative Surgery for FIGO 2018 Stage IB1-IB3 Cervical Cancer (CERVINA Study)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
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.
详细描述
Cervical cancer remains one of the most common gynecologic malignancies worldwide. Neoadjuvant chemotherapy (NACT) has demonstrated favorable response rates in locally advanced cervical cancer; however, pathological complete response (pCR) rates remain limited.
QL1706 is a novel bifunctional PD-1/CTLA-4 antibody combination developed using the MabPair® platform. It consists of the anti-PD-1 antibody iparomlimab and the anti-CTLA-4 antibody tuvonralimab. Previous studies have demonstrated promising antitumor activity in recurrent or metastatic cervical cancer.
This study aims to investigate whether the addition of QL1706 to cisplatin/paclitaxel neoadjuvant therapy can improve pathological response and clinical outcomes in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
Approximately 50 patients will be enrolled. Eligible patients will receive neoadjuvant QL1706 combined with cisplatin and paclitaxel followed by radical surgery. Efficacy will be evaluated using RECIST v1.1 and pathological assessment. Safety will be assessed according to CTCAE v5.0.
Exploratory translational studies will evaluate immune microenvironment changes, molecular biomarkers, and vaginal microbiota alterations associated with treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •ECOG performance status of 0-
- •Adequate organ and bone marrow function.
- •No prior immunotherapy for malignant tumors.
- •Ability to understand and willingness to sign written informed consent.
排除标准
- •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.
- •Known HIV infection.
- •Receipt of live vaccines within 30 days before first dose.
- •Uncontrolled cardiovascular disease.
- •Known hypersensitivity to study drugs.
- •Any condition that, in the investigator's judgment, may interfere with study participation or interpretation of results.