NCT07384416
尚未招募
2 期
QL1706 Combined With Lenvatinib and Nab-Paclitaxel in the Treatment of Recurrent or Refractory Advanced Penile Cancer: a Single Arm, Phase II Study
Sun Yat-sen University0 个研究点目标入组 47 人开始时间: 2026年2月10日最近更新:
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Sun Yat-sen University
- 入组人数
- 47
- 主要终点
- PFS (Progression-Free Survival）
概览
简要总结
The aim of this clinical trial is to evaluate the combination of QL1706, Lenvatinib, and Nab-Paclitaxel for the treatment of recurrent or refractory advanced penile cancer and to assess the safety of this regimen. The main questions it aims to answer are:
- Can the combination of QL1706, Lenvatinib, and Nab-Paclitaxel shrink tumors or prolong the time to disease progression in participants with advanced penile cancer?
- What side effects do participants experience while taking this three-drug combination?
Researchers will compare the tumor response in participants receiving this treatment with historical data from standard therapies to determine whether the new combination is more effective for this type of cancer. This is a single-arm study, meaning all participants will receive the same investigational combination.
Participants will:
- Receive intravenous infusions of QL1706 and Nab-Paclitaxel every 21 days, along with daily oral Lenvatinib capsules.
- Continue treatment cycles until disease progression, unacceptable side effects occur, or they choose to withdraw from the study.
- Attend regular clinic visits for imaging scans (such as CT scans), physical examinations, and blood tests to monitor treatment response and safety.
- Have their tumors measured by scans at scheduled intervals to evaluate treatment efficacy.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Histologically or cytologically confirmed penile squamous cell carcinoma.
- •Previous treatment with chemotherapy, immunotherapy, and/or targeted therapy.
- •At least one measurable target lesion according to RECIST 1.1 criteria.
- •ECOG performance status score of ≤
- •Adequate bone marrow function: Hemoglobin (Hb) ≥ 75 g/L, White Blood Cell count (WBC) ≥ 3.0×10⁹/L, Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L, Platelet count (PLT) ≥ 100×10⁹/L.
- •Adequate organ function:
- •Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.
- •Serum creatinine ≤ 1.5 × ULN.
- •Life expectancy of ≥ 12 months.
排除标准
- •Participation in any investigational drug study within 4 weeks prior to the start of treatment.
- •Concurrent active cancer other than penile squamous cell carcinoma, or a history of other malignancies within the past 5 years, except for the following:
- •(1) Cured non-melanoma skin cancer;
- •(2) Incidentally discovered, low-risk, and curative tumors, including but not limited to low-risk prostate cancer (T1a, Gleason score \<6, PSA \<0.5 ng/ml) and superficial bladder cancer;
- •(3) Other solid tumors that have undergone curative treatment with no evidence of recurrence or metastasis for 5 years or more.
- •Other serious, poorly controlled concurrent illnesses that may be aggravated by the combination therapy, including but not limited to:
- •(1) History of severe or acute exacerbation within the past 6 months involving the cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric systems;
- •(2) Active infection requiring antibiotic treatment within 2 weeks prior to enrollment;
- •(3) Congestive heart failure (Class III-IV);
- •(4) Unstable angina or myocardial infarction within the past 6 months;
研究组 & 干预措施
treatment
Experimental
干预措施: QL1706 + Lenvatinib + Nab-Paclitaxel (Drug)
结局指标
主要结局
PFS (Progression-Free Survival）
时间窗: 2 year
次要结局
- ORR (Objective Response Rate）(week 12)
研究者
ZHOU FANGJIAN
Professor
Sun Yat-sen University
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