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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01975454

Enrollment

Registered

2013-11-04

Start date

2012-04-30

Completion date

2017-12-31

Last updated

2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic colorectal cancer, Chemotherapy, Traditional Chinese Medicine (TCM), Teng-Long-Bu-Zhong-Tang

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.

Interventions

DRUGChemotherapy

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.

DRUGHerbal therapy

TLBZT based herbal decoction administered orally twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival(PFS)	2 months

Secondary

Measure	Time frame
Overall Survival (OS)	2 months
Symptoms	2 months
Adverse events	1 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026