Non-small Cell Lung Cancer(NSCLC)Phase 1CTC-TCM-FZNCT02603003
the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs
A Phase 1 study testing JinFuKang, Cisplatin and Pemetrexed in people with Non-small Cell Lung Cancer(NSCLC), run by Shanghai University of Traditional Chinese Medicine.
Trial summary
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer(NSCLC)
- What is being tested?
- JinFuKang, Cisplatin and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to 1 Sep 2019
- Phase
- Phase 1
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
- Patients receiving chemotherapy for the first time in 6 weeks after surgery;
- Age from 18 Years to 70 Years;
- The liver and renal function were normal,and no other disease.
- Patients compliance is good ang can understand the situation of this study and signed informed consent
Who cannot join
- Patients without clear pathological diagnosis;
- The expected survival period is morn than 6 months;
- Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
- Patients with pregnancy or lactation;
- Persons with a history of less control.
About this study
Official title: A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.
Read the detailed description
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.
- Conditions
- Non-small Cell Lung Cancer(NSCLC)
- Being tested
- JinFuKang, Cisplatin, Pemetrexed
- Keywords
- Circulating tumor cells(CTCs), Traditional Chinese Medicine(TCM), Myeloid-derived suppressor cells(MDSCs)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JinFuKangDrug
Also called Jin Fukang oral liquid
po.tid.30ml
CisplatinDrug
Also called Navelbine
According to the individual patient's condition
PemetrexedDrug
Also called Pemetrexeddisodium for Injection
According to the individual patient's condition
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | Placebo comparator | Cisplatin Receives: Drug: Cisplatin |
| Pemetrexed | Placebo comparator | Pemetrexed Receives: Drug: Pemetrexed |
| Jinfukang | Experimental | Jinfukang Receives: Drug: JinFuKang; Drug: Cisplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
It is decided by a doctor via the clinical examinations
Measured: The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years.
Secondary outcomes (2)
Circulating Tumor Cell
It is decided by a doctor via the clinical examinations
Measured: 24months
Overall survival
It is decided by a doctor via the clinical examinations
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startJun 2015
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer(NSCLC)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jianhuitian, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603003
- Sponsor's protocol ID
- Longhua Hospital
- Other IDs
- TJH20151021, LB20151106
- Acronym
- CTC-TCM-FZ
- Status last verified
- Sep 2019
- First submitted
- 21 Oct 2015
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
- ClinicalTrials.gov ID
- NCT02603003
- Acronym / sponsor ID
- CTC-TCM-FZ / Longhua Hospital
- Conditions
- Non-small Cell Lung Cancer(NSCLC)
- Keywords
- Circulating tumor cells(CTCs), Traditional Chinese Medicine(TCM), Myeloid-derived suppressor cells(MDSCs)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 11 Nov 2015 (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.
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.
Detailed description
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | Placebo comparator | Drug: CisplatinCisplatin |
| Pemetrexed | Placebo comparator | Drug: PemetrexedPemetrexed |
| Jinfukang | Experimental | Drug: JinFuKang, Drug: Cisplatin, Drug: PemetrexedJinfukang |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
- Patients receiving chemotherapy for the first time in 6 weeks after surgery;
- Age from 18 Years to 70 Years;
- The liver and renal function were normal,and no other disease.
- Patients compliance is good ang can understand the situation of this study and signed informed consent
Key exclusion criteria (5 listed)
- Patients without clear pathological diagnosis;
- The expected survival period is morn than 6 months;
- Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
- Patients with pregnancy or lactation;
- Persons with a history of less control.
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 |
|---|---|---|
| JinFuKangAlso: Jin Fukang oral liquidpo.tid.30ml | Drug | Jinfukang |
| CisplatinAlso: NavelbineAccording to the individual patient's condition | Drug | Cisplatin, Jinfukang |
| PemetrexedAlso: Pemetrexeddisodium for InjectionAccording to the individual patient's condition | Drug | Jinfukang, Pemetrexed |
Primary outcome
Progression-Free Survival
Time frame: The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years.
It is decided by a doctor via the clinical examinations
2 secondary outcomes
Circulating Tumor Cell
Time frame: 24months
Overall survival
Time frame: Two years
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 20 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JinFuKang, Cisplatin and Pemetrexed in people with Non-small Cell Lung Cancer(NSCLC), run by Shanghai University of Traditional Chinese Medicine.
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 5 inclusion and 5 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 (time frame: The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2019.