NCT04563975Unknown2 期
Toripalimab Combined With Docetaxel or Nab-paclitaxel in the Treatment of Advanced Gastric Cancer : a Single-arm, Open Label, Prospective Phase II Clinical Trial
Tao Zhang1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年7月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- disease control rate
研究概览
简要总结
The single arm clinical study is to evaluate the efficacy and safety of an anti-PD-1 antibody (Toripalimab) combined with chemotherapy (docetaxel or nab-Paclitaxel) in patients with advanced gastric cancer who failed first-line treatment.
详细描述
54 patients who meet the inclusion criteria will receive Docetaxel (60-75mg/m2, every 3 weeks) or nab-Paclitaxel （125mg/m2，every 3 weeks）combined with Toripalimab( 240mg,every 3 weeks）for 4-8 cycles until the disease progresses or intolerable toxicity.
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
- •Written informed consent from the patient.
- •Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
- •Failure of first-line chemotherapy with fluorouracil ，or adjuvant therapy with fluorouracil drugs, but the end of adjuvant treatment is less than 6 months.
- •Measurable disease as per RECIST 1.1 criteria.
- •Adequate organ and bone marrow functions.
- •Female subjects should agree to use a medically approved effective contraceptive during the study period and for up to 6 months after the study，and must undergo a serum-negative pregnancy test within 72hours before starting the study drug, and out of lactation;male subjects should agree to use medically approved methods of contraception during the study period and within 6 months after the end of the study period.
- •Performance Status(ECOG) 0-
- •Life expectancy >3 months.
排除标准
- •First-line treatment with Taxanes- containing drugs.
- •Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
- •Have received immunosuppressive drugs within 2 weeks before starting the study drug, excluding local glucocorticoids or systemic glucocorticoids<10 mg/day prednisone or other glucocorticoids of equivalent dose.
- •Patients with HIV-positive.
- •Patients with viral hepatitis (such as HBV（hepatitis B virus）, HCV（hepatitis C virus）), HBV-DNA> 2000IU/mL, and unwilling to receive antiviral treatment.
- •History of clinically-significant cardiovascular disease ，Liver diseases such as liver cirrhosis decompensated liver disease, and chronic active hepatitis; poorly controlled diabetes (fasting blood glucose (FBG)>10mmol/L); urine routine indicates urine protein ≥++, and 24-hour urine protein quantitative > 1.0g.
- •Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
- •History of (non-infectious) pneumonitis that required steroids or presence of active pneumonitis.
- •History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
- •Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
- •History of malignant tumors (except for skin basal cell carcinoma and cervical carcinoma in situ treatment with tumor-free survival for more than 3 years.
- •patients with uncontrollable seizures, or loss of insight due to mental illness.
- •History of severe allergies or specific constitution.
- •Participant in other clinical trials within 28 days before study treatment.
研究组 & 干预措施
Chemotherapy and programmed death 1 inhibitor
Experimental
Docetaxel /nab-paclitaxel in combination with Toripalimabs
干预措施: Toripalimab (Drug)
Chemotherapy and programmed death 1 inhibitor
Experimental
Docetaxel /nab-paclitaxel in combination with Toripalimabs
干预措施: Docetaxel (Drug)
Chemotherapy and programmed death 1 inhibitor
Experimental
Docetaxel /nab-paclitaxel in combination with Toripalimabs
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
disease control rate
时间窗: At 12 weeks
disease control rate，According with RECIST 1.1
次要结局
- Complication Rate(Up to 12months)
- overall survival rate(one year)
- progression free survival(Up to 12months)
研究者
Tao Zhang
Chief Physician
Wuhan Union Hospital, China
研究点 (1)
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