A dose escalation and phase IIa study of TG6002 plus flucytosine in patients with unresectable colorectal cancer with liver metastases

TRANSGENE S.A.0 个研究点目标入组 75 人开始时间: 2019年4月2日最近更新: 2020年10月19日

适应症

试验速览

暂无简介。

•1. Histological or cytological diagnosis of colorectal cancer.
•2. Unresectable metastatic colorectal cancer with at least one measurable liver metastasis.
•3. At least one liver metastasis amenable to biopsy.
•4. Patients previously exposed to fluoropyrimidine-based chemotherapy.
•5. (Phase I) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy, or patients on or entering a period of clinical observation without treatment.
•6. (Phase IIa) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1. Predominant extrahepatic disease.
•2. Symptomatic brain metastases or meningeal tumors.
•3. Documented occlusion of the hepatic artery or main portal vein.
•4. Reverse portal vein flow on ultrasound sonography.
•5. Any contraindication to intrahepatic artery infusion procedure including portosystemic shunt, and artery occlusive disease (ceoliac trunk and/or superior mesenteric artery), if it may inhibit catheterization of the hepatic artery.
•6. History of severe exfoliative skin condition (e.g. eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to TG6002 treatment initiation.

发起方

TRANSGENE S.A.