NCT07035808尚未招募2 期
Efficacy and Safety of Iparomlimab and Tuvonralimab(QL1706) Combined With Chemotherapy ± Bevacizumab Induction Therapy Followed by Concurrent Chemoradiotherapy for High-risk Locally Advanced Cervical Cancer：a Single Arm, Phase II Multicenter Clinical Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 46
- 主要终点
- 2-year PFS
研究概览
简要总结
This study is a single arm, phase II multicenter clinical trial to evaluate the efficacy and safety of the combination therapy of Iparomlimab and Tuvonralimab(QL1706) and chemotherapy ± bevacizumab induction therapy followed by concurrent chemoradiotherapy in patients with locally advanced cervical cancer at high risk of IVA stage and/or giant cervical tumors and/or giant metastatic lymph nodes and/or multiple metastatic lymph nodes.
The enrolled patients first receive 2 cycles of combined drug induction therapy: paclitaxel+cisplatin/carboplatin ± bevacizumab+QL1706, every 3 weeks for 2 cycles; After induction therapy, synchronous radiotherapy and chemotherapy combined with immunotherapy: extracorporeal irradiation+post loading radiotherapy+synchronous chemotherapy+immunotherapy. During radiotherapy, single agent cisplatin/carboplatin treatment for 5 courses per week+QL1706 treatment every 3 weeks for 3 courses; After the end of radiotherapy and chemotherapy, immune maintenance therapy will be administered for six months: treatment with QL1706 every 3 weeks for 9 courses, followed by a follow-up period until the end of radiotherapy for 2 years or death.
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
- •Sign a written informed consent before any trial-related procedures.
- •Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
- •Patients with stage Ⅳa confirmed by endoscopic biopsy and/or stage IB3-IIIC (FIGO 2018 staging) with large cervical tumors (maximum diameter ≥ 6 cm) and/or large lymph nodes (maximum short diameter of cross-section ≥ 2 cm) and/or ≥ 3 lymph node metastases confirmed by CT/MR/PET.
- •Female patients aged ≥ 18 years and ≤ 75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Expected survival of more than 6 months.
- •No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy.
- •Major organ functions meet the following requirements: Absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 80×109/L, hemoglobin ≥ 80g/L; Total bilirubin level ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min; Serum albumin ≥ 28g/L; thyroid stimulating hormone (TSH) ≤ 1×ULN (if abnormal, FT3 and FT4 levels should also be examined. If FT3 and FT4 levels are normal, the subject can be enrolled).
- •Subjects agree to use effective contraceptive measures from the time of signing the informed consent until 180 days after the last dose. Women of childbearing age must not be pregnant or lactating.
- •All subjects must be willing to provide tumor tissue samples, blood samples, urine samples, fecal samples, and vaginal secretion samples after enrollment.
排除标准
- •Other histopathological findings such as neuroendocrine carcinoma, sarcoma, gastric-type adenocarcinoma, and malignant melanoma components;
- •Previous receipt of anti-tumor treatment related to cervical cancer;
- •Evidence of distant metastasis, including lymph node metastasis in the groin, supraclavicular, and axillary regions;
- •Previous total hysterectomy or subtotal hysterectomy;
- •Anatomical abnormalities or contraindications that preclude the use of brachytherapy;
- •Previous receipt of any treatment targeting tumor immune mechanisms, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies) or antibodies targeting immune co-stimulatory factors (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40 targets);
- •Patients with other tumors that require current treatment;
- •Active or potentially recurrent autoimmune diseases, except for those that do not require systemic treatment: vitiligo, alopecia, psoriasis or eczema; hypothyroidism caused by autoimmune thyroiditis, requiring stable doses of hormone replacement therapy; type 1 diabetes requiring stable doses of insulin replacement therapy;
- •Patients currently using immunosuppressants or systemic hormones to achieve immunosuppression, and still using them within 2 weeks before enrollment;
- •Poorly controlled clinical symptoms or diseases of the heart, such as (1) NYHA grade 2 or above heart failure; (2) unstable angina pectoris; (3) severe myocardial infarction within 1 year; (4) need for treatment or intervention for clinically significant supraventricular or ventricular arrhythmias; (5) QTc > 450 ms (male), QTc > 470 ms (female);
- •Abnormal coagulation function (INR > 2.0, PT > 16s);
- •Known hereditary or acquired bleeding disorders or thrombophilia (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.);
- •Congenital or acquired immune deficiencies (such as HIV-infected individuals);
- •Patients with HBV DNA > 2000 IU/ml, or HCV RNA > 103, or HBsAg + anti-HCV antibody positive;
- •Active infections that require treatment or use of systemic anti-infective drugs within one week before the first administration;
- •Within 4 weeks before the first administration, received major surgical treatment or had significant trauma or required elective major surgical treatment during the study period.
- •Hypertension, and unable to achieve good control with antihypertensive drugs (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg); previous occurrence of hypertensive crisis or hypertensive encephalopathy;
- •Known that the patient was previously allergic to large molecule protein preparations. Has contraindications and allergies to epalorlimovalovirumab, cisplatin, carboplatin, paclitaxel, bevacizumab, any components thereof;
- •Presence of abnormal results that may interfere with the test results, prevent the subject from fully participating in the study, or laboratory abnormalities that the investigator considers not in the best interests of the subject.
研究组 & 干预措施
treatment group
Experimental
干预措施: 2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy (Combination Product)
结局指标
主要结局
2-year PFS
时间窗: 2 year
2-year PFS rate evaluated by researchers based on RECIST v1.1 and biopsy pathology
次要结局
- ORR(2 year)
- DCR(2 year)
- OS(2 year)
研究者
Hanmei Lou
MD
Zhejiang Cancer Hospital
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