Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No Standard therapy has been approved for third-line therapy of advanced pancreatic cancer. K001 is peptidoglycan prepared from the marine microorganism, with an anti-tumor activity. Previously, the phase I study of K001 has shown that K001 was safety and had some effectiveness for pancreatic patients. Now, we would like to lunch a randomized, blinded, parallel-controlled, multi-center phase II/III study to compare the best support care (BSC) plus K-001 versus BSC plus placebo for the third-line and later treatment of patients with advanced pancreatic cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best Support Care Plus K-001 | Experimental | Best support care including analgesic treatment, anti-infection therapy, biliary obstruction treatment, nutritional support, psychological support, reasonable advice from physicians, good communication with patients and etc. K-001 9,720mg per day which means that take K-001 capsule 18 tablets (270mg per tablet) orally twice a day (morning and evening), 56 days as a cycle. |
|
| Best Support Care Plus placebo | Placebo Comparator | Best support care is the same as experimental arm. Placebo is take 18 placebo tablets which is the same as K-001 in appearance orally twice a day (morning and evening), 56 days as a cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-001 | Drug | K-001 is an antitumor active substance (peptidoglycan) which is prepared from the fermentation product of marine microorganism. K-001 is the Chinese first class new drug and get patent licensing in China, America and Japan. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | The overall survival (OS) of the two groups of FAS was compared. FAS including all the subjects who take at least one dose of the research drug. All the subjects received tumor assessment every 8weeks according to RECIST1.1. | 6 months after the last subject is enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the progression-free survival (PFS) . | 6 months after the last subject is enrolled |
| TTP | All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the time to progression (TTP). |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor marker | blood test to evaluate change of tumor markers, including CEA, CA19-9, CA125, CA724, AFP and etc. of the two groups | 6 months after the last subject is enrolled |
| Hematology Index | blood test to evaluate change of D-Dimer, C-Reactive protein (CRP), Albumin (ALB), CAR (CRP/ALB) of the two groups |
Inclusion Criteria:
Exclusion Criteria:
Patients is not confirmed by pathology/cytology examination as pancreatic ductal adenocarcinoma.
Target lesions were once treated locally and does not exhibit progression recently.
Patients with already diagnosed central nervous system metastasis. Patients with clinical symptoms of central nervous system metastasis should be examined by MRI.
Patients with Vater 's ampullary carcinoma or biliary adenocarcinoma.
Subject with partial or complete intestinal obstruction,or complete biliary obstruction who are unable to be relieved by active treatment
Subject has more than an average of intra-abdominal effusion, or the intra-abdominal effusion could not be control in 2 weeks.
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.
Female subjects who are pregnant, planning a pregnancy or breast feeding during the study.
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.
Subject has an active infection of hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV).
Subject has received any of the following treatment within the framework of a specific time frame prior to entry:
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).
Subject has known to be allergic or intolerant to K-001 and its excipients.
Other situations that the researchers considered inappropriate for inclusion in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiujie Cui, MD | Contact | 86-21-68385559 | cuijiujie@126.com | |
| Xinlei Gong, MD | Contact | 86-25-80864049 | xinleigong@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Liwei Wang, Professor | Renji Hospital, School of Medicine, Shanghai Jiaotong University | Principal Investigator |
| Shukui Qin, Professor | Nanjing Bayi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJiH | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Tow arms were design in the study. Group 1: Best Support Care (BSC) Plus K-001. Group 2: BSC Plus Placebo. The participants were assign into two groups in a 2:1.
Not provided
Not provided
Double Blinded
| placebo | Other | Placebo which looks the same as K-001 in apparence |
|
|
| 6 months after the last subject is enrolled |
| ORR | All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the objective response rate (ORR). | 6 months after the last subject is enrolled |
| DCR | All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the disease control rate (DCR). | 6 months after the last subject is enrolled |
| CBR | According to a questionaire to evaluate the clinical benefit response (CBR) of the two groups. | 6 months after the last subject is enrolled |
| QOL | According to a questionaire to evaluate the quality of life (QOL) of the two groups. | 6 months after the last subject is enrolled |
| 6 months after the last subject is enrolled |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |