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NCT Number: NCT01975454

Study of TLBZT Based Herbal Therapy Plus Chemotherapy for 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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chongqing Three Gorges Central Hospital, Chongqing, Chongqing Municipality, China

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About this study

A phase I/II, multicentric,randomized, controlled clinical trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chemotherapy

Drug

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: Oxaliplatin, Capecitabine

Herbal therapy

Drug

TLBZT based herbal decoction administered orally twice a day

Other names: Traditional Chinese Medicine

Primary outcomes

  1. Progression-free survival(PFS)

    Time frame: 2 months

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 2 months

  2. Symptoms

    Time frame: 2 months

  3. Adverse events

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Chongqing Three Gorges Central Hospital

Registry information

Official study title

A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Nov 4, 2013
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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