NCT06231680招募中2 期
A Prospective, Randomized Clinical Study of the Prevention or Treatment of Camrelizumab-induced Reactive Cutaneous Capillary Endothelial Proliferation (RCCEP) With Thalidomide
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Incidence rate of RCCEP
研究概览
简要总结
To explore the dose and safety of thalidomide for the prevention and treatment of camrelizumab-induced reactive cutaneous capillary endothelial proliferation (RCCEP)
详细描述
- To increase the evidence of thalidomide for the prevention of RCCEP, the investigators will explore the dose of thalidomide for the prevention of RCCEP in participants with esophageal squamous cell carcinoma and non-small cell lung cancer who were scheduled to receive camrelizumab combined with platinum-based chemotherapy;
- To increase the evidence of thalidomide for the treatment of RCCEP, the investigators will explore the dose of thalidomide for the treatment of ≥G2 RCCEP in participants with esophageal squamous cell carcinoma and non-small cell lung cancer with camrelizumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prevention cohort 1:
- •Histopathology or cytology confirmed advanced non-small cell lung cancer or esophageal squamous cell carcinoma; no previous systemic therapy (patients who had progressed ≥6 months after [neo] adjuvant therapy were eligible).
- •A treatment regimen of Camrelizumab combined with platinum-containing chemotherapy is planned.
- •Age ≥18 years old;
- •Have a life expectancy of at least 12 weeks;
- •No prior therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •Can swallow pills normally;
- •Adequate organ and bone marrow function：Standard of blood routine examination (without transfusion within 14 days) : Hemoglobin (HB) ≥80 g/L; Neutrophil absolute value (ANC) ≥1.5×10^9/L; Platelet (PLT) ≥90×10^9/L;Biochemical examination should meet the following criteria: Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3×ULN; Serum creatinine (Cr) ≤1.5 ULN;
- •Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 2 months after the last dose of study treatment. Male Subjects with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception for the course of the study through 2 months after the last dose of study treatment;
- •Subjects has voluntarily agreed to participate by giving written informed consent/assent for the trial.
- •Treatment cohort 2:
- •Histopathology or cytology confirmed advanced lung cancer or esophageal carcinoma;
- •Subjects had≥G2 grade RCCEP for the first time after treatment with a Camrelizumab based regimen;
- •Age ≥18 years old;
- •Have a life expectancy of at least 12 weeks;
- •Can swallow pills normally;
- •No ongoing grade 3 or higher adverse events except for RCCEP (according to CTCAE version 5.0).
- •Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 2 months after the last dose of study treatment. Male Subjects with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception for the course of the study through 2 months after the last dose of study treatment;
- •Subjects have voluntarily agreed to participate by giving written informed consent/assent for the trial.
排除标准
- •Prevention cohort 1:
- •Known allergy to the investigational drug or excipient, history of severe hypersensitivity reactions to other monoclonal antibodies.
- •Subjects with a condition requiring systemic treatment with other immunosuppressive medications within 14 days of first administration of study treatment.
- •Subjects had administration of a live, attenuated vaccine within 4 weeks of the first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study.
- •Advanced patients who have symptoms, have spread to the internal organs, and are at risk of developing life-threatening complications in the short term;
- •Subjects with a history of interstitial lung disease, or other disease may interfere with the detection or treatment of suspected drug-related lung toxicity.
- •Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll.
- •HIV infection; Combined hepatitis B and hepatitis C co-infection
- •Subjects with active CNS metastases are excluded.
- •Subjects with clinically significant cardiovascular and cerebrovascular diseases.
- •Coagulation abnormalities, with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
- •Disposition evidence of hemoptysis in 2 months (bright red blood, 1/2 teaspoon).
- •History of hemorrhage within 3 months prior to the start of study treatment or clear tendency of hemorrhage
- •Thrombosis or thromboembolic event within 6 months prior to the start of study treatment;
- •Active infection (CTCAE> Grade 2)
- •Subjects had or plan to have allogeneic bone marrow transplantation or solid organ transplant.
- •Subjects are currently participating and receiving study therapy or had participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 half-value period life of the agent, before the first dose of trial treatment.
- •Subjects have known psychiatric or substance abuse disorder
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
- •Treatment cohort 2:
- •Known allergy to the investigational drug or excipient
- •Advanced patients who have symptoms, have spread to the internal organs, and are at risk of developing life-threatening complications in the short term;
- •Subjects with a history of interstitial lung disease, or other disease may interfere with the detection or treatment of suspected drug-related lung toxicity.
- •HIV infection; Combined hepatitis B and hepatitis C co-infection
- •Active infection (CTCAE> Grade 2)
- •Subjects have known psychiatric or substance abuse disorder
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator
研究组 & 干预措施
Treatment Cohort 2 Group B
Experimental
Thalidomide(200mg)
干预措施: Thalidomide 200mg (Drug)
Prevention Cohort 1 Group A
Experimental
Camrelizumab + chemotherapy+Thalidomide(50mg)
干预措施: Camrelizumab (Drug)
Prevention Cohort 1 Group A
Experimental
Camrelizumab + chemotherapy+Thalidomide(50mg)
干预措施: Thalidomide 50mg (Drug)
Prevention Cohort 1 Group A
Experimental
Camrelizumab + chemotherapy+Thalidomide(50mg)
干预措施: Chemotherapy (Drug)
Prevention Cohort 1 Group B
Experimental
Camrelizumab + chemotherapy+Thalidomide(100mg)
干预措施: Camrelizumab (Drug)
Prevention Cohort 1 Group B
Experimental
Camrelizumab + chemotherapy+Thalidomide(100mg)
干预措施: Thalidomide 100mg (Drug)
Prevention Cohort 1 Group B
Experimental
Camrelizumab + chemotherapy+Thalidomide(100mg)
干预措施: Chemotherapy (Drug)
Treatment Cohort 2 Group A
Experimental
Thalidomide(100mg)
干预措施: Thalidomide 100mg (Drug)
结局指标
主要结局
Incidence rate of RCCEP
时间窗: 2 years
Incidence rate of RCCEP
RCCEP response rate at 3 weeks
时间窗: 3 weeks
RCCEP response rate at 3 weeks
次要结局
- Incidence rate of ≥G3 grade RCCEP(2 years)
- Median time to RCCEP(2 years)
- Incidence rate of RCCEP at 6 weeks(6 weeks)
- Incidence rate of RCCEP at 9 weeks(9 weeks)
- Median time to response of RCCEP(2 years)
- Thalidomide treatment-related adverse events(2 years)
研究者
Ying Liu
Deputy Chief Physician
Henan Cancer Hospital
研究点 (2)
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