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

NCT01975454 | Completed Phase 1

• 2 other identifiers: TCM-mCRCLHYY-11495801300
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic colorectal cancer; Chemotherapy; Traditional Chinese Medicine (TCM); Teng-Long-Bu-Zhong-Tang

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  2 months

Secondary Outcomes (3)

• Overall Survival (OS)

  2 months

• Symptoms

  2 months

• Adverse events

  1 month

Study Arms (2)

chemotherapy

ACTIVE COMPARATOR

Patients receive chemotherapy until disease progression or unacceptable toxicity

Drug: Chemotherapy

Herbal therapy plus chemotherapy

EXPERIMENTAL

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

Drug: Chemotherapy; Drug: Herbal therapy

Interventions

Chemotherapy DRUG

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.

Also known as: Oxaliplatin, Capecitabine

Herbal therapy plus chemotherapy; chemotherapy

Herbal therapy DRUG

TLBZT based herbal decoction administered orally twice a day

Also known as: Traditional Chinese Medicine

Herbal therapy plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Chongqing Three Gorges Central Hospital: collaborator

Study Sites (2)

Chongqing Three Gorges Central Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

Longhua Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related 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.

  PMID: 23758730 BACKGROUND

• 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. doi: 10.3736/jcim20101108. Chinese.

  PMID: 21078269 BACKGROUND

• 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. doi: 10.3736/jcim20100611. Chinese.

  PMID: 20550881 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Therapy; Oxaliplatin; Capecitabine; Phytotherapy; Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Complementary Therapies; Medicine, East Asian Traditional; Medicine, Traditional

Study Officials

• Bing Hu, MD, PhD

  Shanghai University of Traditional Chinese Medicine

  STUDY CHAIR

• Gang Li, MD

  Chongqing Three Gorges Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 4, 2013
• Study Start: April 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 19, 2018

Record last verified: 2016-10

Locations

CN (2)