Efficacy of Cadonilimab in Combination With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival (PFS) rate
研究概览
简要总结
This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with previously untreated locally advanced cervical cancer, clinically staged as FIGO 2018 stage IB3, IIA2, IIB, or IIIC1r (tumor diameter >4 cm as assessed by contrast-enhanced pelvic MRI);
- •Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- •Female patients aged ≥18 and ≤75 years;
- •Willing and able to provide written informed consent and comply with study visits and protocol-required procedures;
- •Eligible for radical hysterectomy with curative intent;
- •At least one measurable lesion according to RECIST version 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Estimated life expectancy of at least 6 months;
- •Women of childbearing potential must agree to use effective contraception throughout the study period. A negative serum or urine pregnancy test is required before study enrollment.
排除标准
- •Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma.
- •Clinically significant unrecoverable hydronephrosis;
- •CNS metastases or leptomeningeal disease;
- •Active malignancy within 3 years prior to enrollment (with specified exceptions);
- •Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies;
- •Major surgery within 4 weeks before study treatment;
- •Severe cardiovascular or cerebrovascular disease;
- •Unresolved toxicities from previous anticancer therapy (> Grade 1, CTCAE v5.0);
- •Known hypersensitivity to study drugs;
- •Serious medical or psychiatric conditions that may interfere with study participation;
研究组 & 干预措施
Experimental arm
Patients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy/dissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings.
干预措施: Neoadjuvant Therapy Plus Surgery (Procedure)
Control arm
Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy.
干预措施: Concurrent Chemoradiotherapy (Procedure)
结局指标
主要结局
2-year progression-free survival (PFS) rate
时间窗: 2 years after randomization
The proportion of patients who remain alive without radiologically confirmed disease progression at 2 years after randomization. Disease progression will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on imaging evaluations.
次要结局
未报告次要终点