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

Shanghai University of Traditional Chinese Medicine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Herbal therapy; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01975454

LHYY-11495801300 (Registry Identifier)

TCM-mCRC

Details and patient eligibility

About

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.

Full description

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

Enrollment: 62 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

chemotherapy

Active Comparator group

Description:

Patients receive chemotherapy until disease progression or unacceptable toxicity

Treatment:

Drug: Chemotherapy

Herbal therapy plus chemotherapy

Experimental group

Description:

Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity

Treatment:

Drug: Chemotherapy

Drug: Herbal therapy