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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborator: Chongqing Three Gorges Central Hospital
• Treatments: Capecitabine; Oxaliplatin

Criteria

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.