A Randomized, Double-blind, Multicenter Phase Ⅲ Clinical Study of Docetaxel for Injection (Albumin Bound) Combined With Best Supportive Care Versus Placebo Plus Best Supportive Care in Advanced Pancreatic Cancer
Overview
- Phase
- Phase 3
- Intervention
- Docetaxel for Injection (Albumin bound)
- Conditions
- Advanced Pancreatic Cancer
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 142
- Primary Endpoint
- OS
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin Bound) in combination with best supportive care versus placebo in combination with best supportive care in participants with pancreatic cancer who have received gemcitabine-containing and fluorouracil-containing regimens.
Detailed Description
This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin bound) plus best supportive care versus placebo plus best supportive care in participants with pancreatic cancer who have received a previous treatment regimen containing gemcitabine and fluorouracil. It is planned to enroll 142 participants, and participants will be randomized to receive Docetaxel for Injection (albumin bound) in combination with best supportive care or placebo in combination with best supportive care in a 2:1 ratio. Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged ≥18 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form.
- •Histologically or cytologically confirmed diagnosis of pancreatic cancer (including adenosquamous carcinoma).
- •Patients who have got disease progression or toxic intolerance after previous standard treatment (gemcitabine based and fluorouracil based therapy).
- •At least one evaluable lesion according to RECIST 1.1 .
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Patients with fine organ function (no medical supportive treatments such as blood component transfusion, growth factors within 2 weeks before taking the relevant inspections):
- •ANC≥1.5×10\^9/L；
- •PLT≥100×10\^9/L；
- •ALB≥30 g/L；
- •CR≤1.5× ULN and creatinine clearance≥40 mL/min（Cockcroft-Gault）；
Exclusion Criteria
- •Patients who have a history of severe allergy to any excipients of the investigational drug or taxanes，or known allergy and/or contraindications to glucocorticoids (including but not limited to active digestive tract ulcers, severe hypertension, severe hypokalemia, glaucoma, etc.).
- •Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment.
- •Previous history of inflammatory bowel disease, chronic diarrhea, and gastrointestinal bleeding.
- •Patients who had a history of other active malignant tumors within 2 years before the first dose of the investigational drug, except for the study disease pancreatic cancer and curable cancer that had been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ that had been excised).
- •Patients with active hepatitis B (HBsAg and/or HBcAb positive but HBV DNA \< 2000 IU/mL can be included), active hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive.
- •Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for alopecia, hyperpigmentation, or other toxicity without safety risk judged by the investigator).
- •Patients with a history of severe cardiovascular disease, including but not limited to:：
- •Severe heart rhythm or conduction abnormalities, including but not limited to ventricular arrhythmia requiring clinical intervention and third degree atrioventricular block within 6 months before the first dose of the investigational drug；
- •History of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery within 6 months before the first dose of the investigational drug;；
- •Heart failure with New York Heart Association (NYHA) Classification of Class Ш and above；
Arms & Interventions
Docetaxel for Injection (Albumin Bound) in combination with best supportive care
Docetaxel for Injection (Albumin Bound) ：i.v., q3w,100mg/m\^2； Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care
Intervention: Docetaxel for Injection (Albumin bound)
Docetaxel for Injection (Albumin Bound) in combination with best supportive care
Docetaxel for Injection (Albumin Bound) ：i.v., q3w,100mg/m\^2； Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care
Intervention: Best supportive care
Placebo in combination with best supportive care
Placebo ：i.v., q3w； Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care
Intervention: Placebo
Placebo in combination with best supportive care
Placebo ：i.v., q3w； Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care
Intervention: Best supportive care
Outcomes
Primary Outcomes
OS
Time Frame: Up to approximately 2 years
The overall survival (OS) of the two groups. All the participants received tumor assessment every 6 weeks according to RECIST1.1.
Secondary Outcomes
- DCR(Up to approximately 2 years)
- Incidence of AE and SAE(Up to approximately 2 years)
- PFS(Up to approximately 2 years)
- ORR(Up to approximately 2 years)
- PK(At the end of Cycle 1(each cycle is 21 days))
- DOR(Up to approximately 2 years)