A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) With or Without T-ChOS as Adjuvant Therapy in Patients With Surgically Resected Pancreatic Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This is a single center, randomized, double-blind, placebo-controlled phase II trial that will compare the efficacy of T-ChOS in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 months in patients with surgically resected pancreatic adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed informed consent
- •Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded
- •Subject should be able to start treatment no later than 12 weeks post-surgery
- •Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of signing the informed consent form (ICF)
- •ECOG/WHO Performance Status (PS) 0-1
- •Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
- •Agree to the use of two physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study IP; and for 3months following the last dose of IP
- •Has negative serum pregnancy test (β-hCG) result at screening
- •Male subjects:
- •Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy
- •Understand and voluntarily sign an ICF prior to any study related assessments or procedures being conducted
- •Be able to adhere to the study visit schedule and other protocol requirements
- •Acceptable hematology parameters defined as:
- •Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
- •Platelet count ≥ 100 x 10⁹/L
- •Haemoglobin ≥ 5.6 mmol/L
- •Acceptable liver function defined as:
- •Serum bilirubin < 1.5 x upper limit of normal (ULN)
- •ASAT/ALAT < 2.5 x ULN
- •Acceptable renal function with a creatinine clearance ≥ 50 mL/min/ (e.g., using the Cockroft-Gault formula)
排除标准
- •Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
- •Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma
- •Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score ≤ 6, PSA < 0.5 ng/ml), or any other tumor with a DSF survival of ≥ 5 years
- •History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
- •Active infection requiring antibiotics within 2 weeks before the study inclusion
- •Concurrent congestive heart failure NYHA class III - IV
- •Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension
- •History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
- •Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- •Known or suspected allergy to the investigational agents or any agents given in association with this trial
- •Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up
- •Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
- •Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •Any condition that confounds the ability to interpret data from the study
- •Unwillingness or inability to comply with study procedures
- •Current use of anticoagulation therapy such as heparins both unfractionated and low molecular weighted
研究组 & 干预措施
T-ChOS + Gemcitabine + Capecitabine
T-ChOS: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.
Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks.
干预措施: T-ChOS (Dietary Supplement)
T-ChOS + Gemcitabine + Capecitabine
T-ChOS: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.
Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks.
干预措施: Gemcitabine (Drug)
T-ChOS + Gemcitabine + Capecitabine
T-ChOS: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.
Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks.
干预措施: Capecitabine (Drug)
Placebo + Gemcitabine + Capecitabine
Placebo: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.
Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks.
干预措施: Gemcitabine (Drug)
Placebo + Gemcitabine + Capecitabine
Placebo: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.
Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks.
干预措施: Placebo (Dietary Supplement)
Placebo + Gemcitabine + Capecitabine
Placebo: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.
Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: up to approximately 9 months
Time from the date of randomization to the date of disease recurrence or death, whichever is earlier.
次要结局
- Quality of Life(up to approximately 18 months)
- Overall Survival(up to approximately 18 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to approximately 18 months)
研究者
Inna Chen, MD
Staff specialist
Herlev Hospital