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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-12-31

Brief Summary

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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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Detailed Description

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

Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chemotherapy

Patients receive chemotherapy until disease progression or unacceptable toxicity

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type 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.

Herbal therapy plus chemotherapy

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

Group Type EXPERIMENTAL

Chemotherapy

Intervention Type 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.

Herbal therapy

Intervention Type DRUG

TLBZT based herbal decoction administered orally twice a day

Interventions

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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.

Intervention Type DRUG

Herbal therapy

TLBZT based herbal decoction administered orally twice a day

Intervention Type DRUG

Other Intervention Names

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Oxaliplatin Capecitabine Traditional Chinese Medicine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No