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

Phase 1

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Chemotherapy; Drug: Herbal therapy

• Registration Number: NCT01975454
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Primary Completion: 2016-09
• Status Verified: 2016-10
• Study Completion: 2017-12
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Herbal therapy plus chemotherapy	Chemotherapy	Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
chemotherapy	Chemotherapy	Patients receive chemotherapy until disease progression or unacceptable toxicity
Herbal therapy plus chemotherapy	Herbal therapy	Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity

Primary Outcome Measures

Name	Time	Method
Progression-free survival(PFS)	2 months

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 month
Overall Survival (OS)	2 months
Symptoms	2 months

Trial Locations

Locations (2)

Chongqing Three Gorges Central Hospital; 🇨🇳 Chongqing, Chongqing, China

Longhua Hospital; 🇨🇳 Shanghai, Shanghai, China