NCT07311577招募中2 期
Disitamab Vedotin Combined With Platinum and Bevacizumab as First-Line and Maintenance Therapy for HER2-Expressing, HRD-Negative High-Risk Ovarian Cancer: A Multicenter, Non-Randomized, Single-Arm Phase II Clinical Study
Jiangsu Cancer Institute & Hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2026年1月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a prospective, multicenter, phase II study designed to evaluate the efficacy and safety of disitamab vedotin combined with platinum plus bevacizumab as first-line therapy for HER2-expressing, HRD-negative high-risk ovarian cancer. Forty-three patients with pathologically confirmed HRD-negative high-risk ovarian cancer will be enrolled. After enrollment, patients will receive disitamab vedotin plus platinum and bevacizumab as first-line and maintenance treatment.
First-line phase:
Carboplatin AUC 5 intravenously on Day 1 every 21 days over 1 h ,Bevacizumab 7.5-15 mg/kg intravenously on Day 1 every 21 days over 30-90 min.
Maintenance phase:
Patients who achieve response (CR or PR) will continue disitamab vedotin monotherapy plus bevacizumab (investigator decides whether to continue disitamab vedotin and for how long).
Maintenance duration: bevacizumab until disease progression or up to 22 cycles; disitamab vedotin up to 6 months (8 cycles).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation with written informed consent.
- •Age 18-75 years.
- •Expected survival ≥ 12 weeks.
- •Histologically/cytologically confirmed advanced ovarian carcinoma (FIGO Stage III-IV).
- •HRD-negative status per local assessment.
- •High-risk features: macroscopic residual disease after primary cytoreductive surgery for Stage III; prior neoadjuvant chemotherapy; or Stage IV disease.
- •≥ 1 RECIST v1.1 measurable lesion (long-axis ≥ 10 mm by spiral CT or ≥ 15 mm short-axis for lymph nodes).
- •HER2 expression documented locally (IHC 1+, 2+, or 3+); archival or fresh tumor tissue (paraffin block or unstained slides) must be available for central confirmation.
- •ECOG performance status 0-
- •Adequate organ function within 14 days before enrolment (no transfusion/haematinics/G-CSF allowed):
- •Haematology
- •Hb ≥ 90 g/L
- •WBC ≥ 3 × 10⁹/L
- •ANC ≥ 1.5 × 10⁹/L
- •PLT ≥ 90 × 10⁹/L Biochemistry
- •a) TBIL ≤ 1.5 × ULN b) ALT/AST/ALP ≤ 3 × ULN (≤ 5 × ULN if liver metastases) c) Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 60 mL/min (Cockcroft-Gault)
- •Urinalysis: dipstick proteinuria < 2+ or 24-h urine protein < 1 g.
- •Cardiac function: NYHA class < III and LVEF ≥ 50 % by echocardiography. -
- •Women must be surgically sterile, post-menopausal, or use an approved contraceptive method from screening until 6 months after the last dose; serum pregnancy test negative within 7 days of first dose and not breastfeeding.
- •Able and willing to comply with all study and follow-up procedures.
排除标准
- •Non-high-risk histologic sub-types of ovarian carcinoma.
- •CNS metastases and/or carcinomatous meningitis. -
- •Requirement for parenteral hydration/nutrition OR clinical/radiologic evidence of partial bowel obstruction or perforation.
- •≥ Grade-2 peripheral neuropathy. -
- •Active bleeding or high bleeding-risk conditions (e.g., known coagulopathy, tumour encasing major vessels).
- •Interval between cytoreductive surgery and first bevacizumab dose < 28 days.
- •Concurrent malignancy or history of another primary malignancy within 5 years (except adequately treated in-situ cervix cancer, basal- or squamous-cell skin cancer).
- •Major surgery within 4 weeks before first study dose and not fully recovered.
- •Symptomatic or medically-requiring large-volume pleural effusion or ascites. - Live-attenuated vaccine within 30 days before first dose or planned during study.
- •Significant arterial/venous thrombo-embolic or cerebro-cardiovascular event within 12 months before screening (e.g., DVT, PE, cerebral infarction, intracranial haemorrhage, MI); asymptomatic calf-muscle DVT not needing intervention or lacunar infarct without sequelae are allowed.
- •Uncontrolled systemic diseases judged by investigator: diabetes, liver cirrhosis Child-Pugh B/C, interstitial pneumonitis, severe COPD, etc.
- •Clinically-relevant cardiovascular disorders:
- •PR interval > 0.24 s or 2nd/3rd-degree AV block.
- •Uncontrolled hypertension (SBP > 150 mmHg or DBP > 90 mmHg).
- •MI, unstable angina or significant arrhythmia < 6 months before enrolment.
- •NYHA class ≥ II congestive heart failure.
- •Serious arrhythmia requiring anti-arrhythmic therapy.
- •≥ Stage-II peripheral vascular disease (except transient ischaemia < 24 h without permanent deficit and no surgery).
- •Cerebrovascular accident within 6 months.
- •Severe infection within 4 weeks before first dose (IV antibiotics/antifungals/ antivirals required) or unexplained fever > 38.5 °C during screening; major surgery within 3 weeks.
- •Active autoimmune or immunodeficiency disorders (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, RA, IBD, hypophysitis, vasculitis, nephritis). Exceptions: stable hypothyroidism on replacement, type-1 diabetes well controlled with insulin.
- •Autoimmune disease requiring systemic immunosuppressive/immunomodulatory therapy within 2 years before first dose (stable replacement therapy with thyroxine, insulin or physiological corticosteroids permitted).
- •Active or poorly controlled infection, including:
- •HIV positive (HIV-1/2 antibody).
- •Active hepatitis B (HBsAg positive or HBV DNA > 2 000 IU/mL with abnormal LFT).
- •Active hepatitis C (HCV antibody positive or HCV RNA ≥ 10³ copies/mL with abnormal LFT).
- •Active tuberculosis.
- •Other uncontrolled infection > CTCAE v5.0 grade
- •History of other malignancy within 5 years (except adequately treated in-situ cervical cancer or basal/squamous-cell skin cancer). -
- •Concurrent participation in another interventional clinical trial or investigational agent/device within 4 weeks before first dose. -
- •Known hypersensitivity or intolerance to study drugs or their excipients. -
- •History of substance abuse that cannot be abstained from, or any psychiatric disorder that may interfere with compliance.
- •Any other condition that, in the investigator's opinion, could increase risk or preclude safe completion of the protocol.
研究组 & 干预措施
Arm A
Experimental
干预措施: RC48+Carboplatin+Bevacizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From enrollment until 16 months
From enrollment until documented disease progression or death from any cause, whichever occurs first.
次要结局
- Objective Response Rate (ORR)(up to 24 weeks)
- overall survival（OS）(Up to 5 years)
- Disease Control Rate (DCR)(up to 24 weeks)
- Incidents of Adverse Events(30 days after the end of treatment)
研究者
Xiaoxiang Chen
Professor
Jiangsu Cancer Institute & Hospital
研究点 (1)
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