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

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 404000
        • Chongqing Three Gorges Central Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Longhua Hospital

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
Drug: Chemotherapy
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:
  • Capecitabine
  • Oxaliplatin
Experimental: Herbal therapy plus chemotherapy
Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
Drug: Chemotherapy
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:
  • Capecitabine
  • Oxaliplatin
Drug: Herbal therapy
TLBZT based herbal decoction administered orally twice a day
Other Names:
  • Traditional Chinese Medicine

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.

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Chongqing Three Gorges Central Hospital

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

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

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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