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出境医 / 临床实验 / Efficacy of Kangliuwan for Recurrent Grade IV Glioma
Efficacy of Kangliuwan for Recurrent Grade IV Glioma
Study Description
Brief Summary:
A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma.
| Condition or disease |
|---|
| Glioma of Brain Recurrence |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma: A Prospective Exploratory Clinical Study |
| Actual Study Start Date : | June 28, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Changes in tumor volume [ Time Frame: 3 months ]the volume of tumor decreased after taking Kangliuwan
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Recurrent grade IV glioma patients and conventional treatment is invalid.
Criteria
Inclusion Criteria:
- The patient signed "informed consent" voluntarily;
- The age of patient is between 18 and 80 years;
- KPS score ≥40 ; The patient has normal liver and kidney function Normal heart function Better follow-up and compliance;
Exclusion Criteria:
- The patient did not sign "informed consent" or signed unvoluntarily.
- Non-glioma patients
- Active infection
- Human immunodeficiency virus (HIV) positive
- Hepatitis C or hepatitis B infective
- Pregnancy or breast-feeding women
- Patients did not agree to use effective contraception during treatment and the following 3 months.
- Patients also participated in other clinical studies.
- The subjects researchers believe are not suitable for participation or completion of the study.
Contacts and Locations
Contacts
| Contact: Qingtang Lin, MD. Ph.D | 8610-83198362 | linqingtang@xwhosp.orn | |
| Contact: Ge Sun, B.A. | 8610-83198362 | sunge0923@126.com |
Locations
| China, Beijing | |
| Xuanwu Hospital | Recruiting |
| Beijing, Beijing, China, 100054 | |
| Contact: Ge Sun, B.A. 8610-83168899 sunge@163.com | |
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
| Study Chair: | Qingtang Lin, M.D., Ph.D. | Xuanwu Hospital, Beijing | |
| Principal Investigator: | Xiaolan Lin, M.D. | Xuanwu Hospital, Beijing | |
| Principal Investigator: | Ling Chen, M.D. | The General Hospital of People's Liberation Army (301 hospital) |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 11, 2019 | |||||||||
| First Posted Date | May 14, 2019 | |||||||||
| Last Update Posted Date | May 5, 2020 | |||||||||
| Actual Study Start Date | June 28, 2019 | |||||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Changes in tumor volume [ Time Frame: 3 months ] the volume of tumor decreased after taking Kangliuwan
|
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Efficacy of Kangliuwan for Recurrent Grade IV Glioma | |||||||||
| Official Title | Efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma: A Prospective Exploratory Clinical Study | |||||||||
| Brief Summary | A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
|||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Probability Sample | |||||||||
| Study Population | Recurrent grade IV glioma patients and conventional treatment is invalid. | |||||||||
| Condition |
|
|||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
20 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | June 2021 | |||||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| Listed Location Countries | China | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03949192 | |||||||||
| Other Study ID Numbers | LYS [2019] 027 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Qingtang Lin, Xuanwu Hospital, Beijing | |||||||||
| Study Sponsor | Xuanwu Hospital, Beijing | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Xuanwu Hospital, Beijing | |||||||||
| Verification Date | April 2020 | |||||||||
