Phase II study to evaluate the safety, tolerability and efficacy of FOLFOX + CT-011 versus FOLFOX alone administered intravenously to patients with colorectal adenocarcinoma previously untreated for metastatic disease

CureTech Ltd0 个研究点目标入组 171 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.Patients age is 18 years or older, both genders.
•2.Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
•3.ECOG performance status 8804; 1
•4.At least 4 weeks from prior major surgery or radiotherapy.
•5.Life expectancy greater than 3 months
•6.Hematology: ANC 8805; 1.5X109 per Litre; Platelets greater than 100x109 per Litre.
•7.Adequate Renal function
•8.Adequate Hepatic functions
•9.Normal Cardiac function

•1.Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
•2.Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.
•3.Patients on concurrent anti cancer therapy other than that allowed in the study.
•4.Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
•5.Presence of clinically apparent or suspected brain metastasis.
•6.Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
•7.Serious active infection at the time of pre-study screening.
•8.Active or history of autoimmune disorders or conditions.
•9.Women who are pregnant or lactating
•10.Concurrent active malignancy.
•11.Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
•12.Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
•13.Subjects with a condition which may interfere with the subjects ability to understand the requirements of the study.
•14.Patients with history of life threatening allergic reactions to food or drugs
•15.Patients with symptomatic peripheral neuropathy greater than Grade 1.
•16.Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.

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