Angiotensin receptor blockade with losartan plus mFOLFIRINOX versus mFOLFIRINOX alone in advanced Pancreatic AdenoCarcinomas - a two arm open label prospective Phase III parallel design randomized superiority clinical trial - AFPAC

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

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•Inclusion Criteria :
•1. Histologically confirmed adenocarcinoma of the pancreas or ampulla, either by FNAC or biopsy of primary site or metastatic site, with the following specifications
•a. For pancreatic adenocarcinoma - either locally advanced pancreatic cancer (unresectable) or metastatic pancreatic cancer, as per NCCN criteria, 2019
•b. For ampullary adenocarcinoma - metastatic adenocarcinoma alone
•2. Age 18 to 75 years.
•3. ECOG performance status 0 - 1
•4. Patient who can give informed consent for the study.
•5. Patient does not have any contraindications to receive chemotherapy, or Losartan
•6.Adequate hematological, hepatic and renal function parametersÂ·
•7. Systolic Blood pressure > 100mm Hg ( 2 separate readings)
•8. Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography
•9. Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
•10. No major surgery within last 4 weeks
•11. written patient consent form

•Exclusion criteria
•1. Borderline resectable pancreatic cancer, resectable pancreatic cancers, or resectable ampullary cancers
•2.Known hypersensitivity or contraindications against drugs used in the FOLFIRINOX regimen or Losartan
•3.Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA II-IV,
•4.Clinically significant valvular defect
•5.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
•6.Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
•7.Other severe internal disease or acute infection
•8.Baseline neuropathy > NCI Grade II
•9.Chronic inflammatory bowel disease
•10.Unhealed surgical wounds
•11. Severe hemorrhage
•12.Recent hemoptysis
•13.History of GI perforation
•14.Uncontrolled hypertension
•15. Severe/arterial thromboembolism
•16.Bilateral renal Artery stenosis
•17.On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study
•18.Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment

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