NCT01975454

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	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.
DRUG	Herbal therapy	TLBZT based herbal decoction administered orally twice a day

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-09-01
• Completion: 2017-12-01
• First posted: 2013-11-04
• Last updated: 2018-04-19

Locations

2 sites across 1 country: China