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| Name | Class |
|---|---|
| H & J CRO International, Inc. | INDUSTRY |
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The purpose of the study is to explore the efficacy and safety of Kanglaite Injection in the treatment of patients with late-stage cancer cachexia.
The study is a multicenter, prospective, randomized controlled study. The planned sample size is 160 subjects. These subjects will be randomized (1:1) to treatment group (i.e., standard therapy plus Kanglaite Injection) or control group (i.e., standard therapy plus blank control). The study population includes the patients with non small cell lung cancer (adenocarcinoma), colorectal carcinoma and pancreatic carcinoma, who are complicated with cachexia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Kanglaite Injection plus standard therapy. |
|
| Control group | No Intervention | Blank control and standard therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kanglaite Injection | Drug | 200 mL, slow IV drip, once daily for 14 consecutive days, subsequent courses repeated after a 7-day interval. Subjects will be treated for 4 courses (12 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | 77days | |
| Lean body mass | 77days |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival rate (PFS) | 77days | |
| Eastern Cooperative Oncology Group score (ECOG) | 77days | |
| Quality of life score (QOL) |
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Inclusion Criteria:
Exclusion Criteria:
Any pathological type of non-small cell lung cancer (NSCLC) except adenocarcinoma;
Patients who are being treated with chemotherapy, the chemotherapy regimen is not among the regimens specified in the protocol;
Patients with cachexia caused by other reasons, e.g. severe hepatic dysfunction [Aspartate transaminase(AST)/Cerealthirdtransaminase(ALT) >5 times the ULN], severe renal dysfunction (Cr >1.5 times the ULN), uncontrolled thyroid disease, New York Heart Association (NYHA) class III-IV heart failure, AIDS etc.;
Any condition that may hinder the subject's completion of the study, including but not limited to severe uncontrollable organic diseases or infection, unstable angina pectoris, congestive heart failure, etc.;
Patients who are being treated with other anticancer traditional Chinese medicine (TCM), or those who may be treated with TCM after enrollment;
Patients with severe hepatic dysfunction: Scr >=1.5 times the ULN, ALT/AST/alkaline phosphatase (ALP) >=5 times the ULN, total bilirubin (TBIL) >=1.5 times the ULN;
Patients with severe abnormal lipid metabolism [TC>300mg/dl or Triglyceride(TG) >2.5 times the ULN], or those who are in lipid-lowering therapy;
Known or suspected diagnosis of metastatic encephaloma;
In treatment of or plan to receive treatment of molecular targeted drugs, eg,epidermal growth factor receptor
- tyrosine kinase inhibitor (EGFR-TKI), anaplastic lymphoma kinase (ALK) inhibitor, anti-angiogenic agents (including monoclonal antibodies and endostatin), and cetuximab;
Patients present with an ECOG score>2 and require treatment of chemotherapy;
Patients with allergies or intolerability to the investigational product or its excipients;
Patients who are currently included in other clinical trials on antineoplastic drugs;
Patients who are not able to provide the Informed Consent Form (ICF);
Expected survival period is less than 4 months;
Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception (including males);
Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder;
Any condition, in the investigator's opinion, is not in the best interest of the subject (e.g., harming the subject's health) or potentially interferes with the evaluation of treatment according to this protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiying YU | Contact | +8613871382805 | syyu@tjh.tjmu.edu.cn | |
| li Zhang | Contact | +8613554191436 | luzigang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiying YU | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| C499781 | kang-lai-te |
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|
| 77days |
| Survival curve | 77days |
| Overall Survival (OS) | 77days |
| Body Mass Index (BMI) | 77days |
| Serum albumin | 77days |
| Serum Prealbumin | 77days |
| Serum Lactic Acid | 77days |
| Incidence of myelosuppression (%) | 77days |