NSCLCPhase 3NCT03269162
Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection
A Phase 3 study testing Jinfukang Koufuye, Docetaxel and Pemetrexed in people with NSCLC, run by lihegen.
Trial summary
Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Jinfukang Koufuye, Docetaxel and Pemetrexed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2016to 30 Sep 2019
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB
- Accept chemotherapy for the first time 6 weeks after operation
- Age of 18-75 years old
- Eastern Cooperative Oncology Group-PS≤2
- N>1.5×109/L、PLT> 100 × 109/L、Hb>100g/dL、Liver and kidney function is normal or elevated ≤ 1.5 times
- Voluntary participation in the prospective study with signed informed consent
Who cannot join
- No pathology-confirmed diagnosis patients
- Patients with overall survival time<6 months
- Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the same time
- Pregnant or breast feeding patients
- Patients with uncontrollable mentally disease
- Patients with diabetes
About this study
Official title: The Prognosis Study of Postoperative Non-small-cell Lung Cancer Patients Treated Precisely With the Integrated Traditional Chinese and Western Medicine Based on CTC Detection
Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group, N=72). Peripheral blood CTCs and immune cells were detect on five different time points: after operation、4 chemotherapy cycles were over、12 months after operation、18 months after operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life of postoperative patients; and decreasing the side effect of chemotherapy.
- Conditions
- NSCLC
- Being tested
- Jinfukang Koufuye, Docetaxel, Pemetrexed, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jinfukang KoufuyeDrug
30ml per time, tid, po (d6-21, q21)
DocetaxelDrug
75mg/m2,ivgtt 30mins, d1
PemetrexedDrug
500mg/m2, ivgtt 30mins, d1
CisplatinDrug
75mg/m2, ivgtt >2h, d1
| Study group | Role | What they receive |
|---|---|---|
| Jinfukang + Chemotherapy Group | Experimental | Not described Receives: Drug: Jinfukang Koufuye; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin |
| Chemotherapy Group | Placebo comparator | Not described Receives: Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival Rate
From the very beginning of the randomization to the end point when disease relapse or death because of any reason
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start30 Sep 2016
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- lihegen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, lihegen, Shanghai University of Traditional Chinese Medicine
- Investigators
- Hegen Li, Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269162
- Sponsor's protocol ID
- SHDC12016114
- Status last verified
- Sep 2017
- First submitted
- 18 Aug 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognosis Study of Postoperative Non-small-cell Lung Cancer Patients Treated Precisely With the Integrated Traditional Chinese and Western Medicine Based on CTC Detection
- ClinicalTrials.gov ID
- NCT03269162
- Acronym / sponsor ID
- SHDC12016114
- Conditions
- NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- lihegenUniversity, hospital or other
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 31 Aug 2017 (actual)
- 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.
Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group, N=72). Peripheral blood CTCs and immune cells were detect on five different time points: after operation、4 chemotherapy cycles were over、12 months after operation、18 months after operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life of postoperative patients; and decreasing the side effect of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jinfukang + Chemotherapy Group | Experimental | Drug: Jinfukang Koufuye, Drug: Docetaxel, Drug: Pemetrexed, Drug: Cisplatin |
| Chemotherapy Group | Placebo comparator | Drug: Docetaxel, Drug: Pemetrexed, Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB
- Accept chemotherapy for the first time 6 weeks after operation
- Age of 18-75 years old
- Eastern Cooperative Oncology Group-PS≤2
- N>1.5×109/L、PLT> 100 × 109/L、Hb>100g/dL、Liver and kidney function is normal or elevated ≤ 1.5 times
Key exclusion criteria (6 listed)
- No pathology-confirmed diagnosis patients
- Patients with overall survival time<6 months
- Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the same time
- Pregnant or breast feeding patients
- Patients with uncontrollable mentally disease
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 |
|---|---|---|
| Jinfukang Koufuye30ml per time, tid, po (d6-21, q21) | Drug | Jinfukang + Chemotherapy Group |
| Docetaxel75mg/m2,ivgtt 30mins, d1 | Drug | Chemotherapy Group, Jinfukang + Chemotherapy Group |
| Pemetrexed500mg/m2, ivgtt 30mins, d1 | Drug | Chemotherapy Group, Jinfukang + Chemotherapy Group |
| Cisplatin75mg/m2, ivgtt >2h, d1 | Drug | Chemotherapy Group, Jinfukang + Chemotherapy Group |
Primary outcome
Disease-free survival Rate
Time frame: 2 years
From the very beginning of the randomization to the end point when disease relapse or death because of any reason
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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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.
Hegen Li principal investigator
Longhua Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Jinfukang Koufuye, Docetaxel and Pemetrexed in people with NSCLC, run by lihegen.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Sep 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Disease-free survival Rate (time frame: 2 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 14 Sep 2017.