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

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.

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

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.