Efficacy and safety of naltrexone in combination with first-line palliative chemotherapy in metastatic or recurrent locally advanced esophageal carcinoma â?? a randomized integrated phase-II/III study.

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Histologically confirmed squamous cell carcinoma esophageal or gastro-esophageal junction region.
•2. Participants must have metastatic/recurrent/locally advanced disease and planned for palliative chemotherapy
•3. ECOG performance status <=2
•4.Participants must have normal organ and marrow function as defined below:
•a.Leukocytes >=3,000/mcL
•b.Platelets >=100,000/mcL
•c.Total bilirubin <1.5Ã?institutional upper limit of normal
•d. AST(SGOT)/ALT(SGPT) <=5Ã?institutional upper limit of normal
•e. Calculated Creatinine clearance >30 ml/min
•5. The effects of chemotherapy on the developing human fetus are teratogenic. Hence women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

•1.Patients having recurrent disease and planned for definitive therapy would be excluded
•2.Patients who are eligible for targeted therapy
•3.Participants who are receiving any other investigational agents.
•4.Having present or past (within last 2 years) second primary sites of malignancy.
•5.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
•6.Uncontrolled inter-current illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), hepatic failure (Child-Pugh B or C), active gastrointestinal bleeding or obstruction, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.
•7.Pregnant women and breastfeeding women are excluded from this study
•8.HIV-positive, Hepatitis B and C seropositive patients are excluded from this study.
•9.Patients requiring Opioids( Morphine) will be excluded from study

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