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

Study Overview
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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.

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

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

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Chemotherapy
* Drug: Herbal therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: chemotherapy<br>Patients receive chemotherapy until disease progression or unacceptable toxicity | Drug: Chemotherapy<br>* 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.<br>* Other names: Capecitabine;|
| Experimental: Herbal therapy plus chemotherapy<br>Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity | Drug: Chemotherapy<br>* 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.<br>* Other names: Capecitabine;Drug: Herbal therapy<br>* TLBZT based herbal decoction administered orally twice a day<br>* Other names: Traditional Chinese Medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 2 months | 
| Symptoms |  | 2 months | 
| Adverse events |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic colorectal cancer, Chemotherapy, Traditional Chinese Medicine (TCM), Teng-Long-Bu-Zhong-Tang