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

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975454
• Other study ID #: TCM-mCRC
• Secondary ID: LHYY-11495801300
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 23, 2013
• Last updated: April 18, 2018
• Start date: April 2012
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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.
• Herbal therapy
TLBZT based herbal decoction administered orally twice a day

Locations

Country	Name	City	State
China	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing
China	Longhua Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Chongqing Three Gorges Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Deng S, Hu B, An HM, Du Q, Xu L, Shen KP, Shi XF, Wei MM, Wu Y. Teng-Long-Bu-Zhong-Tang, a Chinese herbal formula, enhances anticancer effects of 5--Fluorouracil in CT26 colon carcinoma. BMC Complement Altern Med. 2013 Jun 8;13:128. doi: 10.1186/1472-6882-13-128. — View Citation

Hu B, An HM, Shen KP, DU Q. [Effects of Tenglong Buzhong Decoction on proliferation and apoptosis of human colon carcinoma cell line LS174T]. Zhong Xi Yi Jie He Xue Bao. 2010 Jun;8(6):575-80. Chinese. Erratum in: Zhong Xi Yi Jie He Xue Bao. 2011 Mar;9(3):241. — View Citation

Hu B, An HM, Shen KP, Du Q. [Senescence-inducing effects of Chinese herbal medicine Tenglong Buzhong Decoction on human colon carcinoma LS-174-T cells and the mechanism]. Zhong Xi Yi Jie He Xue Bao. 2010 Nov;8(11):1048-52. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival(PFS)		2 months
Secondary	Overall Survival (OS)		2 months
Secondary	Symptoms		2 months
Secondary	Adverse events		1 month