search
Back to results

Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chemotherapy
Herbal therapy
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic colorectal cancer, Chemotherapy, Traditional Chinese Medicine (TCM), Teng-Long-Bu-Zhong-Tang

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chongqing Three Gorges Central Hospital
  • Longhua Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

chemotherapy

Herbal therapy plus chemotherapy

Arm Description

Patients receive chemotherapy until disease progression or unacceptable toxicity

Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity

Outcomes

Primary Outcome Measures

Progression-free survival(PFS)

Secondary Outcome Measures

Overall Survival (OS)
Symptoms
Adverse events

Full Information

First Posted
October 23, 2013
Last Updated
April 18, 2018
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Chongqing Three Gorges Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01975454
Brief Title
Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer
Official Title
A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Chongqing Three Gorges Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
A phase I/II, multicentric,randomized, controlled clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic colorectal cancer, Chemotherapy, Traditional Chinese Medicine (TCM), Teng-Long-Bu-Zhong-Tang

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
Patients receive chemotherapy until disease progression or unacceptable toxicity
Arm Title
Herbal therapy plus chemotherapy
Arm Type
Experimental
Arm Description
Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Oxaliplatin, Capecitabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Herbal therapy
Other Intervention Name(s)
Traditional Chinese Medicine
Intervention Description
TLBZT based herbal decoction administered orally twice a day
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
2 months
Title
Symptoms
Time Frame
2 months
Title
Adverse events
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Hu, MD, PhD
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gang Li, MD
Organizational Affiliation
Chongqing Three Gorges Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing Three Gorges Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Facility Name
Longhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23758730
Citation
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.
Results Reference
background
PubMed Identifier
21078269
Citation
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.
Results Reference
background
PubMed Identifier
20550881
Citation
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.
Results Reference
background

Learn more about this trial

Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer

We'll reach out to this number within 24 hrs