NCT04669197已完成2 期
A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin+ Hydroxychlororoquine as Preoperative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas
HonorHealth Research Institute2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Normalization Rate of CA 19-9
研究概览
简要总结
To evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has histologically or cytologically confirmed resectable, borderline resectable, or locally advanced (unresectable) PDAC (based upon Tempero et al 2016)
- •Age ≥ 18 years.
- •If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (≥β-hCG) documented within 72 hours of the first administration of study drug
- •If sexually active, the patient and partner must agree to use contraception considered adequate and appropriate by the Investigator
- •Patient must have received no prior chemotherapy or radiation therapy for PDAC
- •Patients must have normal organ and marrow function
- •Patient has acceptable coagulation status as indicated by an INR ≤ 1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.
- •Karnofsky Performance Status (KPS) of ≥70%.
- •Have an elevated CA 19-9 (>2X ULN) in the context of normal bilirubin
排除标准
- •Patient will be excluded from this study if any of the following criteria apply: Evidence of metastatic disease. No metastatic disease defined as any one or more of the following; Suspicious lymphadenopathy outside of the standard surgical field (i.e. aortocaval nodes, distant abdominal nodes) or Radiographic evidence for metastatic disease in distant organs, peritoneum, or ascites
- •Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- •Known infection with HIV, hepatitis B, or hepatitis C.
- •Has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- •History of allergy or hypersensitivity to the study drugs.
- •Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
- •Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
- •Patient is unwilling or unable to comply with study procedures.
- •Patient is enrolled in an industry sponsored clinical trial involving treatment with investigational therapy. Patients enrolled in HonorHealth sponsored research studies may be eligible to participate as long as their participation in the other research studies does not confound the data collected for this study.
- •Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
- •Use of non-FDA approved cannabinoids are prohibited. Total daily usage of up to 40 mg per day of marinol is acceptable.
- •Exclusion Criteria for Hydroxychloroquine Expansion Cohort only:
- •Prolonged QTcF > 450 ms for men and > 470 ms for women at Screening. Electrolyte imbalances (e.g. hypokalemia/hypomagnesemia/hypocalcemia) must be corrected prior to first dose of hydroxychloroquine.
- •Known second or third degree atrioventricular block.
- •Patient is taking a concomitant medication that has "known" risk of QT prolongation or torsdades de pointe.
- •Patient has pre-existing retinopathy.
- •Patient has known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds.
研究组 & 干预措施
Treatment
Other
Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine
干预措施: Paclitaxel protein bound (Drug)
Treatment
Other
Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine
干预措施: Gemcitabine (Drug)
Treatment
Other
Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine
干预措施: Cisplatin (Drug)
Treatment
Other
Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Normalization Rate of CA 19-9
时间窗: 6 months
Evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.
CA 19-9 Normalization
时间窗: From enrollment to the end of study, up to 30 weeks.
Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected on Day 1 of every treatment cycle (approximately 21 days/cycle); CA 19-9 normalization after 2 or more treatment cycles was measured.
次要结局
- Survival Rate(2 years)
- Resectability Rate(6 months to 2 years)
- Response Rate(6 months to 2 years)
- Incidence of Treatment-Emergent Adverse Events(6 months to 2 years)
- Overall Survival(Every 12 weeks from study entry, up to 32 months.)
- Adverse Events Related to Study Agents(From enrollment to end of study, up to 30 weeks.)
- Resectability Rate (R0)(After end of treatment, from 6 months up to 2 years.)
- Pathologic Complete Response Rate (pCR)(After end of treatment, from 6 months up to 2 years.)
- Radiological Response - Complete Response (CR) or Partial Response (PR)(From enrollment to end of study, up to 30 weeks.)
- Radiological Response - All Responses(From enrollment to the end of study, up to 30 weeks.)
- 2-Year Survival(2 years after study completion)
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic CancerMetastatic Pancreatic CancerNCT01621243Momenta Pharmaceuticals, Inc.128
招募中
不适用
Phase II study of modified nab-paclitaxel plus gemcitabine in elderly patients over 75 years with unresectable advanced pancreatic cancerJPRN-UMIN000038738Aichi Medical University40
终止
1 期
Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer PatientsPancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical ResectionNCT01198522Philogen S.p.A.28
招募中
2 期
Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancerbreast cancerJPRN-UMIN000006428Toho University Omori Medical Center40
招募中
2 期
Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast CancerBreast cancerJPRN-UMIN000009152Toho University Omori Medical Center40