Metastatic Colorectal CancerPhase 1/2NCT01975454
Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer
A Phase 1/2 study testing Chemotherapy and Herbal therapy in people with Metastatic Colorectal Cancer, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Chemotherapy and Herbal therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2012to Dec 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000
Longhua Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
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.
Read the detailed description
A phase I/II, multicentric,randomized, controlled clinical trial.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Chemotherapy, Herbal therapy
- Keywords
- Metastatic colorectal cancer, Chemotherapy, Traditional Chinese Medicine (TCM), Teng-Long-Bu-Zhong-Tang
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called Oxaliplatin, Capecitabine
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 therapyDrug
Also called Traditional Chinese Medicine
TLBZT based herbal decoction administered orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Active comparator | Patients receive chemotherapy until disease progression or unacceptable toxicity Receives: Drug: Chemotherapy |
| Herbal therapy plus chemotherapy | Experimental | Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity Receives: Drug: Chemotherapy; Drug: Herbal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Measured: 2 months
Secondary outcomes (3)
Overall Survival (OS)
Measured: 2 months
Symptoms
Measured: 2 months
Adverse events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startApr 2012
- Primary completionSep 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Three Gorges Central Hospital
- Responsible party
- Sponsor
- Investigators
- Bing Hu, MD, PhD, Study chair, Longhua HospitalGang Li, MD, Principal investigator, Chongqing Three Gorges Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975454
- Sponsor's protocol ID
- TCM-mCRC
- Other IDs
- LHYY-11495801300
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2013
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23758730Hu 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.
PubMed 21078269Hu 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.
PubMed 20550881
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01975454
- Acronym / sponsor ID
- TCM-mCRC
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, Chemotherapy, Traditional Chinese Medicine (TCM), Teng-Long-Bu-Zhong-Tang
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Chongqing Three Gorges Central Hospital
- Study start
- Apr 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Active comparator | Drug: ChemotherapyPatients receive chemotherapy until disease progression or unacceptable toxicity |
| Herbal therapy plus chemotherapy | Experimental | Drug: Chemotherapy, Drug: Herbal therapyPatients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: Oxaliplatin, CapecitabineOxaliplatin (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. | Drug | Herbal therapy plus chemotherapy, chemotherapy |
| Herbal therapyAlso: Traditional Chinese MedicineTLBZT based herbal decoction administered orally twice a day | Drug | Herbal therapy plus chemotherapy |
Primary outcome
Progression-free survival(PFS)
Time frame: 2 months
3 secondary outcomes
Overall Survival (OS)
Time frame: 2 months
Symptoms
Time frame: 2 months
Adverse events
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Background: PubMed 23758730Deng 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.
- Background: PubMed 21078269Hu 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.
- Background: PubMed 20550881Hu 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.
- Individual participant dataSharing planned: Undecided
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bing Hu, MD, PhD study chair
Longhua Hospital
Gang Li, MD principal investigator
Chongqing Three Gorges Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chemotherapy and Herbal therapy in people with Metastatic Colorectal Cancer, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01975454, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.