Non-small Cell Lung Cancer Stage INCT05097417
Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
A study testing traditional Chinese medicine and ablation in the primary tumor sites and ablation in people with Non-small Cell Lung Cancer Stage I, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Lung cancer is the leading cause of cancer related mortality. At present, surgical treatment is the main choice for early-stage lung cancer. Even after surgery, the 5-year recurrence rate is still as high as 18.4%-24%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage I
- What is being tested?
- traditional Chinese medicine and ablation in the primary tumor sites and ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Nov 2024
- Phase
- Interventional
- 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
- The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
- Patients with lung nodule.
- Maximum diameter of lung nodule ≥8mm.
- The pathology of lung nodules biopsy was non-small cell lung cancer.
- I period according to the eighth edition of the TNM staging period.
- No mediastinal lymph node metastasis.
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- Eastern Cooperative Oncology Group performance status of 0 to 1.
- No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
- Sufficient organ functions.
Who cannot join
- Patients with previous use of various hormones, immunosuppression or autoimmune diseases.
- Women during pregnancy or breast-feeding.
- Patients with severe heart, lung, kidney disease or other systemic diseases
- Patients with severe hemorrhagic diseases.
- Patients with a history of drug abuse or mental illness.
- Other conditions that the investigator has determined are not suitable for participation in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 86200072
Lihong Fan, M.D.
About this study
Official title: A Prospective Open-Label Randomized Study of Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
Lung cancer is the leading cause of cancer related mortality. At present, surgical treatment is the main choice for early-stage lung cancer. Even after surgery, the 5-year recurrence rate is still as high as 18.4%-24%. Traditional Chinese medicine combined with thermal and cold ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to evaluate the efficacy of traditional Chinese medicine combined with thermal and cold ablation for patients with stage I non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer Stage I
- Being tested
- traditional Chinese medicine and ablation in the primary tumor sites, ablation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Chinese medicine and ablation in the primary tumor sitesCombination product
Patients will be treated with traditional Chinese medicine and ablation in the primary tumor sites
ablationProcedure or surgery
Patients will be treated with ablation in the primary tumor sites
| Study group | Role | What they receive |
|---|---|---|
| traditional Chinese medicine combined with thermal or cold ablation | Experimental | Not described Receives: Combination Product: traditional Chinese medicine and ablation in the primary tumor sites |
| thermal or cold ablation | Active comparator | Not described Receives: Procedure: ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported. Objective response rate is the sum of CR + PR divided by the total number of patients in each group.
Measured: 2 years after ablation
Secondary outcomes (1)
DFS
The time interval from the first medication to the observation of recurrence or metastasis, or death from any cause (calculated based on the previous event). Patients who have not relapsed, metastasized or died at the time of the data cutoff, and those who were lost to follow-up in the study will be counted on the date of their last tumor evaluation.
Measured: 2 years after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2024 (estimated)
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 Stage IStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Li, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097417
- Sponsor's protocol ID
- 2021SH10
- Status last verified
- Oct 2021
- First submitted
- 29 Jun 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-Label Randomized Study of Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
- ClinicalTrials.gov ID
- NCT05097417
- Acronym / sponsor ID
- 2021SH10
- Conditions
- Non-small Cell Lung Cancer Stage I
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 28 Oct 2021 (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.
Lung cancer is the leading cause of cancer related mortality. At present, surgical treatment is the main choice for early-stage lung cancer. Even after surgery, the 5-year recurrence rate is still as high as 18.4%-24%. Traditional Chinese medicine combined with thermal and cold ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to evaluate the efficacy of traditional Chinese medicine combined with thermal and cold ablation for patients with stage I non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional Chinese medicine combined with thermal or cold ablation | Experimental | Combination Product: traditional Chinese medicine and ablation in the primary tumor sites |
| thermal or cold ablation | Active comparator | Procedure: ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
- Patients with lung nodule.
- Maximum diameter of lung nodule ≥8mm.
- The pathology of lung nodules biopsy was non-small cell lung cancer.
- I period according to the eighth edition of the TNM staging period.
Key exclusion criteria (6 listed)
- Patients with previous use of various hormones, immunosuppression or autoimmune diseases.
- Women during pregnancy or breast-feeding.
- Patients with severe heart, lung, kidney disease or other systemic diseases
- Patients with severe hemorrhagic diseases.
- Patients with a history of drug abuse or mental illness.
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 |
|---|---|---|
| traditional Chinese medicine and ablation in the primary tumor sitesPatients will be treated with traditional Chinese medicine and ablation in the primary tumor sites | Combination product | traditional Chinese medicine combined with thermal or cold ablation |
| ablationPatients will be treated with ablation in the primary tumor sites | Procedure or surgery | thermal or cold ablation |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years after ablation
Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported. Objective response rate is the sum of CR + PR divided by the total number of patients in each group.
1 secondary outcome
DFS
Time frame: 2 years after ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional Chinese medicine and ablation in the primary tumor sites and ablation in people with Non-small Cell Lung Cancer Stage I, run by Shanghai 10th People's Hospital at 1 site 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 9 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Contact Lihong Fan, M.D. (+8613661599588, fanlih@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 2 years after ablation). 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 28 Oct 2021.