NCT07466901尚未招募不适用
A Single-arm, Multicenter, Phase II Clinical Study of Camrelizumab Combined With Famitinib in Adjuvant Therapy After Radical Resection of Cervical Cancer
Jin LI1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2-year disease-free survival rate
研究概览
简要总结
This study is a single-arm, open-label, multicenter, exploratory clinical trial aimed at observing and evaluating the efficacy and safety of camrelizumab combined with famitinib in the adjuvant treatment of cervical cancer patients after surgery.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old, female;
- •No prior systemic anti-tumor treatment (including chemotherapy, radiotherapy, or other investigational treatments);
- •PD-L1 test result: CPS ≥ 1;
- •Presence of measurable lesions at baseline according to RECIST 1.1 criteria;
- •Pathological types: squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma;
- •FIGO 2018 stage: IA, IB1-2, IIA1, IB3, IIA2;
- •ECOG PS: 0-1;
- •Expected survival period > 3 months;
- •Good function of major organs, meeting the following criteria:
- •Blood routine examination (without blood transfusion or use of hematopoietic stimulating factors to correct the condition within 14 days): hemoglobin (Hb) ≥ 90g/L; absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelets (PLT) ≥ 90×10⁹/L;
- •Biochemical examination: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (for patients with liver metastases, ≤ 5×ULN); serum total bilirubin (TBIL) ≤ 1.5×ULN (for subjects with Gilbert syndrome, ≤ 3×ULN); serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance ≥ 60mL/min;
- •Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN;
- •Urinalysis shows urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification should be < 1g;
- •Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
- •Women of childbearing age must agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study and within 6 months after the end of the study; serum or urine pregnancy test within 7 days before enrollment must be negative, and they must be non-lactating patients; male patients must agree to use contraceptive measures during the study and within 6 months after the end of the study;
- •Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
排除标准
- •Patients participating in other clinical trials at the same time, unless they are in an observational, non-interventional clinical study or the follow-up period of an interventional study;
- •Subjects with rare histopathological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc.;
- •Subjects who have had other malignant tumors within 3 years before enrollment, except for cervical cancer. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, breast carcinoma in situ, etc.;
- •A history of allergic reactions, hypersensitivity reactions, or intolerance to antibody-based drugs; a history of significant allergies to drugs, food, or other substances;
- •Those with no measurable lesions or unevaluable lesions;
- •Having received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks before the first dose;
- •Having received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first dose;
- •Having active autoimmune diseases requiring systemic treatment within the past two years;
- •Having a history of non-infectious pneumonia requiring systemic glucocorticoid treatment, a history of pneumonia, or a current history of interstitial lung disease;
- •Having a history of immunodeficiency; positive HIV antibody test; currently receiving long-term systemic corticosteroids or other immunosuppressants;
- •A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- •Subjects with evidence or history of thrombosis or obvious bleeding tendency within 2 months before the first administration of the study drug (bleeding > 30 mL within 2 months, with hematemesis, melena, hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks);
- •Having uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; known HIV infection or AIDS history; active syphilis; active tuberculosis; active infection; uncontrolled hypertension, symptomatic cardiac insufficiency; active bleeding;
- •Pregnant or lactating women;
- •Active or uncontrolled severe infections (≥ CTCAE5.0 grade 2 infections), including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia, and unexplained fever > 38.5℃ before the first dose;
- •A clear history of mental disorders (including epilepsy or dementia); or other conditions that the investigator deems inappropriate for participation in the study;
- •Patients who the investigator judges are unlikely to comply with the study procedures, restrictions, and requirements must not participate in this study.
研究组 & 干预措施
camrelizumab combined with famotinib
Experimental
Camrelizumab combined with famitinib for adjuvant therapy after radical resection of cervical cancer
干预措施: Camrelizumab (Drug)
camrelizumab combined with famotinib
Experimental
Camrelizumab combined with famitinib for adjuvant therapy after radical resection of cervical cancer
干预措施: famotinib (Drug)
结局指标
主要结局
2-year disease-free survival rate
时间窗: 2 years after treatment
The proportion of cancer patients without recurrence, metastasis, or tumor-related death within 2 years after treatment, for evaluating short-term efficacy.
次要结局
未报告次要终点
研究者
Jin LI
Principal Investigator
Fudan University
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast CancerBreast CancerNCT07380646Second Affiliated Hospital, School of Medicine, Zhejiang University94
尚未招募
1 期
An Open-label, Single-arm, Prospective, Multicenter, Phase I/II Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Relapsed/Refractory Warm Antibody Autoimmune Hemolytic AnemiaNCT07324889Yihao Wang24
尚未招募
2 期
Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell LymphomasNCT07387848American University of Beirut Medical Center40
尚未招募
2 期
SYS6002 vs PADCEV in Patients With Advanced Urothelial CarcinomaNCT07374549CSPC Megalith Biopharmaceutical Co.,Ltd.100
招募中
2 期
Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary AdenocarcinomaNCT07314216Hunan Cancer Hospital15