Clinical trial NCT01975454: Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer
Official title: A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic colorectal cancer
Chemotherapy
Traditional Chinese Medicine (TCM)
Teng-Long-Bu-Zhong-Tang
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Chongqing Three Gorges Central Hospital
First posted: 2013-11-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 2 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2 months
measure: Symptoms
timeFrame: 2 months
measure: Adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chongqing
city: Shanghai
country: China
facility: Longhua Hospital
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Bing Hu, MD, PhD
role: STUDY_CHAIR
affiliation: Chongqing Three Gorges Central Hospital
name: Gang Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.3736/jcim20101108. Chinese.
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. doi: 10.3736/jcim20100611. Chinese.