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.
1. Patients aged ≥18 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form.
2. Histologically or cytologically confirmed diagnosis of pancreatic cancer (including adenosquamous carcinoma).
3. Patients who have got disease progression or toxic intolerance after previous standard treatment (gemcitabine based and fluorouracil based therapy).
4. At least one evaluable lesion according to RECIST 1.1 .
1. 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.).
2. Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment.
3. Previous history of inflammatory bowel disease, chronic diarrhea, and gastrointestinal bleeding.
4. 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).
Parallel
Docetaxel for Injection (Albumin bound)
DrugDocetaxel for Injection (Albumin bound), by intravenous infusion, every 3 weeks.
Placebo
DrugPlacebo was human blood albumin without the active ingredient docetaxel
Best supportive care
DrugBest supportive care includes, but is not limited to, pain control, nutritional support, and psychological care.
OS
The overall survival (OS) of the two groups. All the participants received tumor assessment every 6 weeks according to RECIST1.1.
PFS
All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the progression-free survival (PFS) .
ORR
All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the objective response rate (ORR).
DCR
All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the disease control rate (DCR).
DOR
All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the duration of response (DOR).
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