Nab-paclitaxel Plus Carboplatin Combined Endostatin Versus Solvent-based Paclitaxel Plus Carboplatin in the Treatment of Advanced Melanoma After the Failure of PD-1 Treatment #A Randomized Controlled, Open, Multicenter Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This is a randomized controlled clinical trial of nab-paclitaxel + carboplatin
- Endostatin for advanced melanoma after failure of PD-1 therapy. The aim was to evaluate the efficacy and safety of nab-paclitaxel+carboplatin
- endostatin versus combination of paclitaxel and carboplatin in patients with advanced melanoma after failure of PD-1 therapy.
详细描述
The enrollment time is expected to be 1.5 year and the observation time is 2 years. The regimen were performed on a 28-day/21-day cycle respectively. Subjects who met the entry criteria were treated in a 2:1 group according to a randomized list: the treatment group was treated with nab-paclitaxel + carboplatin + endostatin regimen, and the control group was treated with paclitaxel + carboplatin. In this trial, the efficacy is evaluated every 8 weeks until disease progression or unacceptable toxicity,or until the investigator deemed that the patient's condition was unacceptable for further treatment. The follow-up period was 24 months after the end of treatment (follow-up patient survival information and new anti-tumor treatment). The planning enrolled sample size for nab-paclitaxel + carboplatin + endostatin group and paclitaxel-carboplatin group were 90 patients and 45 patients, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, ≤ 70 years old, male or female;
- •Histological or pathological diagnosis of advanced melanoma, and progressed after anti-PD-1 treatment (disease progression or unacceptable toxicity);
- •The patient has at least one (RECIST 1.1 standard) measurable lesion, which needs to be detected by spiral CT or MRI, and the tumor lesion has at least one single diameter ≥ 1 cm;
- •ECOG PS is 0 or 1 (see Annex 1 for standards);
- •The estimated survival period is ≥12 weeks;
- •no chemotherapy contraindications, including normal peripheral blood, liver and kidney function and electrocardiogram are basically normal; Peripheral blood: neutrophils ≥1.5×109/L, platelets≥90×109/ L, hemoglobin≥90 g/L; Renal function: normal serum creatinine; For patients with non-metastatic liver function impairment: alanine, aspartate aminotransferase ≤ 2.5 ULN, For patients with metastatic liver dysfunction: alanine, aspartate aminotransferase ≤ 5 ULN;
- •Patients who have undergone topical treatment for asymptomatic brain metastases can be enrolled and have a clinical stable status of at least 4 weeks.
- •Patients voluntarily participate in and sign an informed consent form.
- •contraindications for the use of no carboplatin, paclitaxel, entropic and albumin paclitaxel
排除标准
- •Known HIV, hepatitis B/C virus positive status or history of active tuberculosis (testing prior to randomisation is not required)
- •Received any investigational drug within 28 days or 5 half-lives of the planned first dose of this study treatment.
- •Active infection requiring systemic therapy.
- •A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low-risk of recurrence.
- •Patients with a history or evidence of cardiovascular risk,
- •History or evidence of interstitial lung disease or active non-infectious pneumonitis.
- •Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance.
- •Pregnant or breastfeeding females, or expecting to conceive or father children within the projected period of study treatment (52 weeks followed by 4 months following end of study treatment).
研究组 & 干预措施
nab-paclitaxel + endostatin+ carboplatin
nab-paclitaxel + endostatin+ carboplatin nab-paclitaxel 260mg/m2, d1 +Carboplatin AUC=5, d1 +endostatin 15mg, d1-14 q28d
干预措施: Chemotherapeutic Combinations (Drug)
paclitaxel+carboplatin
paclitaxel+carboplatin paclitaxel 175 mg/m2, d1+ Carboplatin AUC=5, d1 q21d
干预措施: chemotherapy (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 3 years
The time from treatment to tumor progression or death
次要结局
- overall survival (OS)(3 years)
- Disease Control Rate (DCR)(At the end of Cycle 2 (each cycle is 28 days))
- Objective response rate (ORR)(At the end of Cycle 2 (each cycle is 28 days))
- Adverse events (AE)(3 years)
研究者
Jun GUO
Vice President of Beijing Cancer Hospital，Head of renal carcinoma & melanoma dept.
Peking University Cancer Hospital & Institute