- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01975454
Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer
April 18, 2018 updated by: Shanghai University of Traditional Chinese Medicine
A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Teng-Long-Bu-Zhong-Tang (TLBZT) is a modern anti-cancer herbal formula.
Experimental studies have confirmed the anti-cancer potential of TLBZT against colorectal cancer.
This trial will evaluate the safety and efficacy of TLBZT based herbal therapy in combination with chemotherapy in patients with metastatic colorectal cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A phase I/II, multicentric,randomized, controlled clinical trial.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
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Chongqing, Chongqing, China, 404000
- Chongqing Three Gorges Central Hospital
-
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Shanghai
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Shanghai, Shanghai, China, 200032
- Longhua Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the colon or rectum with non-resectable metastatic disease;
- Ages between 18 and 70 years;
- Measurable lesion;
- Karnofsky Performance Status ≥ 60%;
- Estimated life expectancy of at least 6 months;
- Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥90g/L, N > 1.5×10^9/L, platelet≥ 100×10^9/L, normal liver and kidney function;
- Informed consent from the patient.
Exclusion Criteria:
- Symptomatic brain metastasis;
- Adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
- Serious disease of heart, liver, kidney with severe dysfunction;
- Serious complications, such as gastrointestinal tract obstruction and hemorrhage;
- Pregnancy or breast-feeding women;
- Mental or cognitive disorders;
- Be participating other drug trials;
- Who are allergic to the study drug.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: chemotherapy
Patients receive chemotherapy until disease progression or unacceptable toxicity
|
Oxaliplatin (130 mg/m2) was given intravenously (iv) for at least 2 h on day 1; Capecitabine (1000 mg/m2) was given orally, twice daily on days 1-14.
Each cycle was 21 days.
Cycles were repeated until disease progression or unacceptable toxicity.
Other Names:
|
Experimental: Herbal therapy plus chemotherapy
Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
|
Oxaliplatin (130 mg/m2) was given intravenously (iv) for at least 2 h on day 1; Capecitabine (1000 mg/m2) was given orally, twice daily on days 1-14.
Each cycle was 21 days.
Cycles were repeated until disease progression or unacceptable toxicity.
Other Names:
TLBZT based herbal decoction administered orally twice a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival(PFS)
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: 1 month
|
1 month
|
Overall Survival (OS)
Time Frame: 2 months
|
2 months
|
Symptoms
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Bing Hu, MD, PhD, Shanghai University of Traditional Chinese Medicine
- Principal Investigator: Gang Li, MD, Chongqing Three Gorges Central Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Deng S, Hu B, An HM, Du Q, Xu L, Shen KP, Shi XF, Wei MM, Wu Y. Teng-Long-Bu-Zhong-Tang, a Chinese herbal formula, enhances anticancer effects of 5--Fluorouracil in CT26 colon carcinoma. BMC Complement Altern Med. 2013 Jun 8;13:128. doi: 10.1186/1472-6882-13-128.
- Hu B, An HM, Shen KP, Du Q. [Senescence-inducing effects of Chinese herbal medicine Tenglong Buzhong Decoction on human colon carcinoma LS-174-T cells and the mechanism]. Zhong Xi Yi Jie He Xue Bao. 2010 Nov;8(11):1048-52. doi: 10.3736/jcim20101108. Chinese.
- Hu B, An HM, Shen KP, DU Q. [Effects of Tenglong Buzhong Decoction on proliferation and apoptosis of human colon carcinoma cell line LS174T]. Zhong Xi Yi Jie He Xue Bao. 2010 Jun;8(6):575-80. doi: 10.3736/jcim20100611. Erratum In: Zhong Xi Yi Jie He Xue Bao. 2011 Mar;9(3):241. Chinese.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
October 28, 2013
First Posted (Estimate)
November 3, 2013
Study Record Updates
Last Update Posted (Actual)
April 19, 2018
Last Update Submitted That Met QC Criteria
April 18, 2018
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- TCM-mCRC
- LHYY-11495801300 (Registry Identifier: Longhua Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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