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.
A phase I/II, multicentric,randomized, controlled clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
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.
TLBZT based herbal decoction administered orally twice a day
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Longhua Hospital
Shanghai, Shanghai Municipality, China
Progression-free survival(PFS)
Time frame: 2 months
Overall Survival (OS)
Time frame: 2 months
Symptoms
Time frame: 2 months
Adverse events
Time frame: 1 month
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