Clinical trial · Interventional
Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer
A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
NCT01975454CI-TRIAL-00032591completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Herbal therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy
- description
- Patients receive chemotherapy until disease progression or unacceptable toxicity
- interventionNames
- Drug: Chemotherapy
- type
- EXPERIMENTAL
- label
- Herbal therapy plus chemotherapy
- description
- Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
- interventionNames
- Drug: Chemotherapy
- Drug: Herbal therapy
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDDeng 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
- BACKGROUNDHu 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
- BACKGROUNDHu 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