Phase II study of resection of primary colorectal caner and synchronous liver metastasis after S-1 + oxaliplatin (SOX) + Bevacizumab(Bmab) therapy and adjuvant S-1 chemotherapy - Colorectal cancer with synchronous liver metastasis

Morohashi Hajime0 个研究点目标入组 28 人开始时间: 2019年3月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Hitologically confirmed colon or rectal cancer
•2) With priary lesion on colon or rectal cancer
•3) With primary and synchronous liver metastasis without other metastasis
•4) With evaluable lesion
•5) Where a surgeon judged hepatectomy is possible. As a measure of initially unresectable liver metastasis, it is assumed that the residual liver volume after hepatectomy is expected to be less than 30% even by portal vein embolism
•6) Without extrahepatic lesions other than the primary lesion
•1. Without pulmpnary metastasis by X-P or CT
•2. Without hepatic and paraaortic lymph node swelling by CT
•7) Age of 20-75 years
•8) Without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy)
•9) Aadequate function of important organs
•1. WBC: >=3,000/mm3 and 12,000/mm3
•2. Neutrophil: >=1,500/mm3
•3. Platelet: >=100,000/mm3
•4. Hemoglobin: >=9.0g/dL
•5. T Bil: <=2.0mg/dL
•6. AST, ALT: <100IU/L
•7. Serum creatinine: <=1.2mg.DL
•8. Creatinin clearance level >= 60mi/min
•9. Urine protein<=1+
•10. INR<=1.5
•10) ECG: without clinically problematic abnormalities within 28 days before registration
•11) Eastern Cooperative Oncology Group performance status (PS) 0-1
•12) With ability of oral intake
•13) Established stoma because of a primary lesion accompanied with high stenosis that does not allow the endoscope to pass
•14) Written informed concent

•1) with gastrointestinal ulceration or bleeding
•2) with sensory neuropathy
•3) with severe diarrhea
•4) had a previous serious drug allergies
•5) had pleural effusion or ascites which need therapy
•6) with brain metastasis or suspected the brain metastases
•7) had surgery within 28 days before registration
•8) had thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
•9) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
•10) with active double cancer
•11) had active infection disease (over 38.0 degree)
•12) with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris)
•13) receiving Flucytosine
•14) pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant
•15) had hemoptysis (2.5 ml or more of fresh blood)
•16) had gastrointestinal perforation within 6 months
•17) were systemically-administered of steroids
•18) with contraindications to TS-1, L-OHP, and Bevacizumab
•19) with HBsAg-positive
•20) Physician will determine that the patient is inappropriate participate in this trail for the safety.

发起方

Morohashi Hajime