KCT0003167招募中未知
eoadjuvant CCRT with Gemcitabine/Durvalumab (MEDI4736) followed by adjuvant Gemcitabine/Durvalumab(MEDI4736) in resectable or borderline resectable pancreatic cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 71
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Written informed consent and any locally-required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •2.Age=19 years at time of study entry
- •3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4.Life expectancy of > 3months
- •5.Histologically proven pancreatic ductal adenocarcinoma
- •6.Resectable or borderline resectable based on AJCC Cancer staging system (8th ed)
- •7.Chemotherapy –naïve for their pancreatic cancer
- •8.Body weight >30kg (for durvalumab monotherapy or durvalumab + novel)
- •9.Adequate normal organ and marrow function as defined below: (NOTE TO AUTHOR: These are minimum criteria for studies in subjects with solid tumors and may need to be altered based on individual study requirements; please adjust as necessary)
- •?Haemoglobin = 9.0 g/dL
- •?Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)
- •?Platelet count = 100 (or 75) x 109/L (>75,000 per mm3)
- •?Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- •?AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be = 5x ULN
- •?Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
- •10.Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
- •11.Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
排除标准
- •1.Participation in another clinical study with an investigational product during the last 3 weeks
- •2.Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- •3.Any previous immunotherapy including PDL1 or CTLA4 inhibitor
- •4.Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug
- •5.Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction (this can be removed if testing durvalumab alone and retain this exclusion if combining durvalumab with novel agents)
- •6.Current or prior use of immunosuppressive medication within 14days (before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion:
- •-Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)
- •-Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent
- •- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
- •?Subjects with any diagnostic procedure-related events that are not reversed
- •?Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
- •7.NCI CTCAE grade 2 or higher toxicity of previous chemotherapy that have not yet been resolved.
- •8. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
- •9.Subjects receiving extensive radiation treatment or radiation therapy for sites that exceed 30% of the bone marrow within 4 weeks prior to the first dose of IP.
- •10.Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- •11.History of allogenic organ transplantation.
- •12.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- •?Subjects with vitiligo or alopecia
- •?Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
- •?Any chronic skin condition that does not require systemic therapy
- •?Subjects without active disease in the last 5 years may be included but only after consultation with the study physician
- •?Subjects with celiac disease controlled by diet alone
- •13.Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial
研究者
相似试验
进行中（未招募）
2 期
Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic CancerPancreatic CancerNCT03572400Do-Youn Oh71
已完成
不适用
eoadjuvant combined chemotherapy with gemcitabine, cisplatin and zoledronic acid against muscle invasive bladder cancerbladder cancerJPRN-UMIN000003146Department of Urology, Graduate School of Biomedical Sciences Hiroshima University30
已完成
2 期
eoadjuvant chemotherapy with gemcitabin plus carboplatin for triple negative breast cancerbreast cancerJPRN-UMIN000030215Showa University30
已完成
2 期
Adjuvant chemotherapy using gemcitabine+ CDDPin patients with resected biliary cancer, phase II studyresected bile duct cancerJPRN-UMIN000010501Dokkyo Medical Uniiversity28
招募中
不适用
eoadjuvant chemoradiation combined with gemcitabine and cisplatin for biliary tract cancerJPRN-UMIN000020964Osaka Medical Center for Cancer and Cardiovasuclar diseasese20