EUCTR2012-002400-40-ES进行中（未招募）1 期
A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients with Resected Adenocarcinoma of the Pancreas - Not applicable
Targovax AS0 个研究点目标入组 32 人开始时间: 2015年7月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
- •2. Stage I or II disease (clinical stage T1-3, N0-1, M0 by AJCC staging criteria).
- •3. Successful surgical resection
- •-Complete resection (R0) or with microscopic residual disease (R1)
- •-Expected to receive gemcitabine monotherapy as adjuvant chemotherapy
- •4. Laboratory Values:
- •-Absolute neutrophil count more than or equal to 1.5 x 10exp9/l
- •-Platelets more than or equal to 100 x 10exp9/l
- •-Haemoglobin more than or equal to 9 g/dl
- •-Total bilirubin less than or equal to 1.5 x UNL
- •-Serum creatinine less than or equal to 1.5 x UNL
- •-Albumin more than or equal to 2.5 g/dl
- •-AST or ALT less than or equal to 5 x UNL
- •5. 18 years of age or older.
- •6. ECOG performance status (PS) of 0-1.
- •7. Life expectancy of at least 6 months
- •8. Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy
- •9. Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Has received an investigational drug within 4 weeks prior to Trial drug administration
- •2. Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy)
- •3. Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma)
- •4. Has any other serious illnesses or medical conditions such as, but not limited to:
- •-Any uncontrolled infection
- •-Uncontrolled cardiac failure classification III or IV (NY Heart Association)
- •-Uncontrolled systemic and gastro-intestinal inflammatory conditions
- •-Bone marrow dysplasia
- •-History of auto-immune disease
- •-History of adverse reactions to vaccines
- •5. Known history of positive tests for HIV/AIDS, hepatitis B or C
- •6. Pregnant or lactating females or have no pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
- •7. Contraindication to Gemcitabine treatment
- •8. Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
- •9. Known malignant brain lesion(s)
- •10. Are unlikely to start chemotherapy within 12 weeks of surgery (e.g. delayed wound healing, or infection, etc.)
- •11. Are not expected to complete 6 cycles of chemotherapy
- •12. Are planned to receive yellow fever or live (attenuated) vaccines during the course of study (see prohibited medications).
研究者
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