A Phase III, Multicenter, Open-label, Randomized Controlled Clinical Study on the Treatment of Locally Advanced Cervical Cancer With Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV)
研究概览
简要总结
This study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be enrolled, subjects had to meet all of the following criteria:
- •Female, aged 18-70 years (inclusive of cutoff values);
- •Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix;
- •Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy;
- •At least one measurable lesion according to RECIST v1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1;
- •Have adequate organ function.
排除标准
- •Subjects were excluded from the study if they met any of the following criteria:
- •Distant metastatic disease (including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 pyramid in the proximal cephalic region, according to FIGO 2018 stage IVB);
- •He had undergone total hysterectomy (removal of the corpus uteri and cervix);
- •Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities;
- •Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
- •Had any condition that was deemed by other investigators to be ineligible for participation in the trial.
研究组 & 干预措施
Standard concurrent chemoradiotherapy（CCRT）
Accept standard concurrent chemoradiotherapy
干预措施: standard EBRT+Brachytherapy (Radiation)
Standard concurrent chemoradiotherapy（CCRT）
Accept standard concurrent chemoradiotherapy
干预措施: Concurrent chemotherapy (Drug)
Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab
Undergo immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.
干预措施: Immune induction therapy (Drug)
Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab
Undergo immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.
干预措施: Reduced dose radiotherapy (Radiation)
Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab
Undergo immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.
干预措施: Dose reduction concurrent chemotherapy (Drug)
Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab
Undergo immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.
干预措施: Immunomaintenance therapy (Drug)
Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab
Undergo immune induction chemotherapy combined with reduced-dose radiotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.
干预措施: Immune induction therapy (Drug)
Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab
Undergo immune induction chemotherapy combined with reduced-dose radiotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.
干预措施: Reduced dose radiotherapy (Radiation)
Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab
Undergo immune induction chemotherapy combined with reduced-dose radiotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.
干预措施: Immunomaintenance therapy (Drug)
结局指标
主要结局
Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV)
时间窗: Up to approximately 55 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
次要结局
- Objective Response Rate (ORR) per RECIST 1.1(Up to approximately 55 months)
- Overall Survival (OS)(Up to approximately 55 months)
- Duration of Response (DOR) per RECIST 1.1(Up to approximately 3 years)
- Time to Response (TTR) per RECIST 1.1(Up to approximately 3 years)
- Disease Control Rate (DCR) per RECIST 1.1(Up to approximately 3 years)
研究者
Guiling Li
PHD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology