CTRI/2024/03/064939尚未招募3 期
Phase III RCT comparing chemotherapy to chemotherapy plus immunotherapy in patients with advanced esophageal squamous cell cancer receiving first line palliative intent systemic therapy (NICE Study). - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Subjects must have histologically proven squamous cell carcinoma of the oesophagus and must be planned for palliative intent systemic therapy
- •2 Subjects must be treatment naïve or if they have received systemic therapy in the curative setting it must be greater than or equal to 3 months prior.
- •3 Age Male or female or Transgender subjects aged greater than or equal to 18 years.
- •4 Eastern Cooperative Oncology Group ECOG performance status PS 0 to 2.
- •5 Subjects must have normal organ and marrow function as defined below
- •a Hematologic Absolute neutrophil count ANC greater than or equal to 1.0 multiplied by 109 per L platelet count greater than or equal to 100 multiplied by 109 per L and haemoglobin greater than or equal to 8 g per dL .
- •b Hepatic Total bilirubin level less than or equal to 1.5 multiplied by the upper limit of normal ULN range and AST and ALT levels less than or equal to 2.5 multiplied by ULN or AST and ALT levels less than or equal to 5 multiplied by ULN for subjects with documented metastatic disease to the liver.
- •c Renal Estimated creatinine clearance greater than or equal to 30 mL per min
- •6 Patients with HIV are potentially eligible as long as they have a CD4 count greater than 200 are on concurrent HAART highly active antiretroviral therapy and absence of active AIDS defining conditions.
- •7 Pregnancy test Negative serum or urine pregnancy test at screening for women of childbearing potential.
- •8 Contraception Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last Nivolumab treatment administration if the risk of conception exists. The effects of Nivolumab on the developing human foetus are teratogenic. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study she should inform her treating physician immediately.
- •9 Both men and women of all races and ethnic groups are eligible for this study.
- •10 Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •1 Subjects who are receiving any other concurrent investigational agents.
- •2 Immunosuppressants Current use of immunosuppressive medication EXCEPT for the following a intranasal inhaled topical steroids or local steroid injection e g intraarticular injection b Systemic corticosteroids at physiologic doses less than or equal to 10 mg per day of prednisone or equivalent c Steroids as premedication for hypersensitivity reactions eg CT scan premedication d Steroids for raised intracranial pressure due to the disease itself eg Steroid use for avoidance or treatment of emesis.
- •3 Autoimmune disease Active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Patients with diabetes type I vitiligo psoriasis or hypo or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- •4 Organ transplantation Prior organ transplantation including allogeneic stemcell transplantation.
- •5 Infections Active infection requiring systemic therapy.
- •6 Hepatitis Hepatitis B virus HBV or hepatitis C virus HCV infection at screening positive HBV surface antigen with a raised HBV DNA or anti HCV antibody screening test positive with raised HCV RNA. Mere presence of HBV or HCV at screening test wont rule the patient out.
- •7 Vaccination Vaccination within 4 weeks of the first dose of Nivolumab and while on study is prohibited except for administration of inactivated vaccines.
- •8 Hypersensitivity to study drug Known prior severe hypersensitivity to investigational product or any component in its formulations.
- •9 Cardiovascular disease Clinically significant ie active cardiovascular disease unstable angina congestive heart failure greater than or equal to New York Heart Association Classification Class II or more or serious uncontrolled cardiac arrhythmia .
- •10 Other persisting toxicities Persisting toxicity related to prior therapy NCI CTCAE v4 03 Grade greater than or equal to 2 however alopecia sensory neuropathy Grade less than or equal to 2 or other Grade less than or equal to 2 not constituting a safety risk based on Investigators judgment is acceptable.
- •11 Other severe acute or chronic medical conditions including immune colitis inflammatory bowel disease immune pneumonitis chronic kidney disease chronic liver disease pulmonary fibrosis or psychiatric conditions including recent within the past year or active suicidal ideation or behaviour
- •12 Pregnant women are excluded from this study. Advise females of reproductive potential to use effective contraception during treatment and for at least one month after the last dose of Nivolumab.
- •13 Lactating females There is no information regarding the presence of Nivolumab in human milk the effects on the breastfed infant or the effects on milk production. Since many drugs are excreted in human milk it is advised that a lactating woman should not breastfeed during treatment and for at least one month after the last dose of Nivolumab due to the potential for serious adverse reactions in breastfed infants.
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