NCT06942416招募中2 期
Phase II, Single-Arm, Multicenter Clinical Study of Iparomlimab and Tuvonralimab in Combination With Paclitaxel Plus Cisplatin/Carboplatin and Radiotherapy for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer
Shandong Cancer Hospital and Institute1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年2月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin/carboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are:
- Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?
- What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?
Participants will:
- Receive iparomlimab and tuvonralimab, Paclitaxel + Cisplatin/Carboplatin and radiation therapy according to a specified protocol.
- Visit the clinic for regular checkups and tests throughout the treatment period.
- Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.
- Provide hematologic、tissue and stool samples to explore biomarkers.
This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic cervical cancer as well as identify biomarkers to better guide treatment strategies.
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
- •Signed written informed consent prior to any trial-related procedures;
- •Female, aged ≥18 and ≤75 years;
- •ECOG PS 0-1;
- •Histologically or cytologically confirmed primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial diagnosis, meeting clinical diagnostic criteria;
- •Locally recurrent or oligometastatic cervical cancer after initial treatment. Total recurrent + metastatic lesions ≤5.Oligometastasis criteria:Lymph node metastases within the same region = 1 lesion;Liver metastases ≤1 lesion;Lung metastases ≤3 lesions
- •At least one measurable lesion (including primary lesion) suitable for radiotherapy and evaluable per RECIST v1.1;
- •Available tumor tissue sample for biomarker assessment;
- •Expected survival ≥6 months;
- •Normal organ function (within 7 days pre-enrollment):
- •(1) Hematological criteria (no transfusion/granulocyte/platelet-stimulating drugs within 14 days):
- •Hemoglobin (Hb) ≥80 g/L
- •Absolute neutrophil count (ANC) ≥1.5×10⁹/L
- •Platelets (PLT) ≥50×10⁹/L (2) No functional organic disease:
- •a) ALT/AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, ALP ≤3×ULN, albumin ≥30 g/L b) Serum Cr ≤1.5×ULN (if >1.5×ULN, CrCl ≥50 mL/min by Cockcroft-Gault formula) c) PT prolongation ≤6 sec, APTT ≤1.5×ULN d) TSH ≤ULN (if abnormal, FT3/FT4 must be normal) f) LVEF >50%
- •Prior anti-tumor treatment toxicities recovered to ≤Grade 1 (CTCAE v5.0) pre-treatment, excluding:
- •Alopecia/pigmentation (any grade)
- •Peripheral neuropathy (≤Grade 2)
- •Other toxicities where benefit-risk favors treatment
- •Non-sterilized/childbearing-potential females must:
- •Use medical contraception (IUD/oral contraceptives/condoms) during treatment + 3 months post-treatment
- •Negative serum/urine HCG within 7 days pre-enrollment
- •Non-lactating
- •Expected compliance with protocol follow-up following criteria:
- •Prior immunotherapy (e.g., immune checkpoint inhibitors);
- •Pathological diagnosis of gastric-type adenocarcinoma;
- •Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Exceptions: vitiligo; childhood asthma fully resolved without intervention in adulthood. Exclusion: asthma requiring bronchodilator therapy;
- •Current use of immunosuppressants or systemic/absorbable topical corticosteroids (equivalent to >10 mg/day prednisone) for immunosuppression, continued within 2 weeks before enrollment;
- •History of Grade 3-4 immune-related adverse events (irAEs) associated with prior anti-tumor immunotherapy;
- •Poorly controlled cardiac conditions:
- •NYHA Class II or higher heart failure
- •Unstable angina
- •Myocardial infarction within 6 months
- •Clinically significant supraventricular/ventricular arrhythmia requiring treatment
- •QTc >450 ms (males) or >470 ms (females);
- •Coagulation abnormalities (INR >1.5 or PT >16 s), bleeding tendency, or current thrombolytic/anticoagulant therapy;
- •Prior radiotherapy/chemotherapy/hormonal therapy/surgery/targeted therapy completed <4 weeks before study treatment (or <5 drug half-lives, whichever is longer); unresolved toxicities (excluding alopecia) from prior therapies >CTCAE Grade 1;
- •Poorly controlled third-space effusion requiring drainage before first trial drug administration;
- •Significant hemoptysis (≥2.5 mL/day) within 2 months before randomization;
- •Known hereditary/acquired bleeding/thrombotic disorders (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism);
- •Active infection or unexplained fever >38.5°C during screening/before first dose;
- •Objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction;
- •Immunodeficiency (e.g., HIV infection) or active hepatitis:
- •HBV DNA > upper limit of normal (ULN)
- •HCV RNA > ULN;
- •Use of other investigational drugs within 4 weeks before first dose; radiotherapy/local therapy within 2 weeks without full recovery;
- •Concurrent/prior malignancies (except cured basal cell carcinoma/cervical carcinoma in situ);
- •Planned concurrent systemic anti-tumor therapy during the study;
- •Live vaccination within 4 weeks before treatment or planned during the study;
- •Other conditions potentially requiring study termination per investigator judgment:
- •Severe comorbidities (including psychiatric disorders) requiring treatment
- 另有 2 项未显示
排除标准
- 未提供
研究组 & 干预措施
Chemotherapy+Immunotherapy+Radiotherapy
Experimental
Chemotherapy：TP (Paclitaxel and Cisplatin/Carboplatin); Immunotherapy：Iparomlimab and Tuvonralimab;Radiotherapy：All tumor lesions will be irradiated
干预措施: Paclitaxel and Cisplatin/ Carboplatin (Drug)
Chemotherapy+Immunotherapy+Radiotherapy
Experimental
Chemotherapy：TP (Paclitaxel and Cisplatin/Carboplatin); Immunotherapy：Iparomlimab and Tuvonralimab;Radiotherapy：All tumor lesions will be irradiated
干预措施: Iparomlimab and Tuvonralimab (Drug)
Chemotherapy+Immunotherapy+Radiotherapy
Experimental
Chemotherapy：TP (Paclitaxel and Cisplatin/Carboplatin); Immunotherapy：Iparomlimab and Tuvonralimab;Radiotherapy：All tumor lesions will be irradiated
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression-Free Survival
时间窗: Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months
Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first.
次要结局
- Objective Response Rate(Assessed every 6 weeks via imaging until study completion (up to 24 months)
- Overall Survival(The time interval from enrollment to death from any cause, assessed up to 60 months)
- Disease Control Rate(Assessed every 6 weeks via imaging until study completion (up to 24 months）)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Before each chemotherapy cycle (each cycle is 21 days), at 24 hours pre- and post-radiotherapy, and every 3 months during follow-up (up to 24 months))
研究者
Peng Xie
Director
Shandong Cancer Hospital and Institute
研究点 (1)
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