Advanced Pancreatic Cancer
Conditions
Interventions
Experimental:Best Support Care Plus K-001 Best support care including analgesic treatment,anti-infection therapy, biliary obstruction treatment,nutritional support, psychological support, reasonable a
Placebo Comparator:Best Support Care Plus placebo Best support care is the same as experimental arm. Placebo is take 6 placebo tablets which is the same as K-001 in appearance orally twice a day (morn
Sponsors
Shanghai Jiaotong University School of Medicine, Renji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Older than 18 years; 2. Metastatic or locally advanced pancreatic ductal adenocarcinoma which is confirmed by primary and/or metastatic pathology/cytology examination; 3. Had received at least 2 lines chemotherapy regimen, and the disease is progression or the toxicity could not be tolerated; 4. At least 28 days after the last chemotherapy; 5. Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1); 6. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; 7. Adequate hepatic, renal, and hematologic functions (neutrophils=1.5×10^9/L, platelets = 80×10^9/L,hemoglobin =90g/L, total bilirubinwithin 2.0×the upper limit of normal(ULN), albumin=30g/L, and ALT and AST=3×the ULN (If liver metastases, serum transaminase=5×the ULN), serum creatine = 1.5 x ULN and creatinine clearance rate > 30ml/min (Cockcroft-Gault); 8. For women of child-bearing age, the pregnancy test results (serum or urine) within 14 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 60 days post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 60 days post the last administration of study drug; 9. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.;Inclusion criteria: 1. Older than 18 years; 2. Metastatic or locally advanced pancreatic ductal adenocarcinoma which is confirmed by primary and/or metastatic pathology/cytology examination; 3. Had received at least 2 lines chemotherapy regimen, and the disease is progression or the toxicity could not be tolerated; 4. At least 28 days after the last chemotherapy; 5. Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1); 6. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; 7. Adequate hepatic, renal, and hematologic functions (neutrophils=1.5×10^9/L, platelets = 80×10^9/L,hemoglobin =90g/L, total bilirubinwithin 2.0×the upper limit of normal(ULN), albumin=30g/L, and ALT and AST=3×the ULN (If liver metastases, serum transaminase=5×the ULN), serum creatine = 1.5 x ULN and creatinine clearance rate > 30ml/min (Cockcroft-Gault); 8. For women of child-bearing age, the pregnancy test results (serum or urine) within 14 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 60 days post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 60 days post the last administration of study drug; 9. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
Exclusion criteria: 1. Patients is not confirmed by pathology/cytology examination as pancreatic ductal adenocarcinoma; 2. Target lesions were once treated locally and does not exhibit progression recently; 3. Patients with already diagnosed central nervous system metastasis. Patients with clinical symptoms of central nervous system metastasis should be examined by MRI; 4. Patients with Vater's ampullary carcinoma or biliary adenocarcinoma; 5. Subject with partial or complete intestinal obstruction,or complete biliary obstruction who are unable to be relieved by active treatment; 6. Subject has more than an average of intra-abdominal effusion, or the intra-abdominal effusion could not be control in 2 weeks; 7. Subject has a second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers treated with curative intent and no known active disease within 5 years before planned start of study therapy; 8. Female subjects who are pregnant, planning a pregnancy or breast feeding during the study; 9. Subject has an active infection, or a hypertension could not be controlled by drugs, or angina diagnosed within 3 months, or unstable angina pectoris, or myocardial infarction diagnosed within 1 year, or with congestive heart failure (New York Heart Association [NYHA] Class II; or III or IV), or with schizophrenia, or with the history of psychotropic substance abuse. 10. Subject has an active infection of hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV); 11. Subject has received any of the following treatment within the framework of a specific time frame prior to entry: (1) received operation greater than grade II within 4 weeks; (2) received extended range radiotherapy within 4 weeks, or locally radiotherapy within 2 weeks; (3) participated in other therapeutic/interventional clinical trials within 4 weeks; (4) received locally anti-tumor therapy within 4 weeks. 12. All toxic effects of any prior antitumor therapy resolved to Grade < 2 before the start of study therapy (with the exception of alopecia and pigmentation of skin); 13. Subject has known to be allergic or intolerant to K-001 and its excipients; 14. Other situations that the researchers considered inappropriate for inclusion in this study.;Exclusion criteria: 1. Patients is not confirmed by pathology/cytology examination as pancreatic ductal adenocarcinoma; 2. Target lesions were once treated locally and does not exhibit progression recently; 3. Patients with already diagnosed central nervous system metastasis. Patients with clinical symptoms of central nervous system metastasis should be examined by MRI; 4. Patients with Vater's ampullary carcinoma or biliary adenocarcinoma; 5. Subject with partial or complete intestinal obstruction,or complete biliary obstruction who are unable to be relieved by active treatment; 6. Subject has more than an average of intra-abdominal effusion, or the intra-abdominal effusion could not be control in 2 weeks; 7. Subject has a second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers treated with curative intent and no known active disease within 5 years before planned start of study therapy; 8. Female subjects who are pregnant, planning a pregnancy or breast feeding during the study; 9. Subject has an active infection, or a hypertension could not be controlled by drugs, or angina diagnosed within 3 months, or unstable angina pectoris, or myocardial infarction diagnosed within 1 year, or with congestive heart failure (New York Heart Association [NYHA] Class II; or III or IV), or with schizophrenia, or with the history of psychotropic substance abuse. 10. Subject has an active infection of hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV); 11. Subject has received any of the following treatment within the framework of a specific time frame prior to entry: (1) received operation greater than grade II within 4 weeks; (2) received extended range radiotherapy within 4 weeks, or locally radiotherapy within 2 weeks; (3) participated in other therapeutic/interventional clinical trials within 4 weeks; (4) received locally anti-tumor therapy within 4 weeks. 12. All toxic effects of any prior antitumor therapy resolved to Grade < 2 before the start of study therapy (with the exception of alopecia and pigmentation of skin); 13. Subject has known to be allergic or intolerant to K-001 and its excipients; 14. Other situations that the researchers considered inappropriate for inclusion in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS);time to progression (TTP);objective response rate (ORR);disease control rate (DCR);clinical benefit response (CBR);;progression-free survival (PFS);time to progression (TTP);objective response rate (ORR);disease control rate (DCR);clinical benefit response (CBR); | — |
Primary
| Measure | Time frame |
|---|---|
| overall survival;;overall survival; | — |
Countries
China
Contacts
Public ContactLiwei Wang, Professor;Liwei Wang, Professor ;
Shanghai Jiaotong University School of Medicine, Renji Hospital;Shanghai Jiaotong University School of Medicine, Renji Hospital
Outcome results
None listed