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

NCT01975454 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-04-19

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Herbal therapy

TLBZT based herbal decoction administered orally twice a day

Sponsors & Collaborators

  • Chongqing Three Gorges Central Hospital

    collaborator OTHER

  • Shanghai University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Bing Hu, MD, PhD · Shanghai University of Traditional Chinese Medicine

  • Gang Li, MD · Chongqing Three Gorges Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-09-30
Completion
2017-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975454 on ClinicalTrials.gov