Effect IncreasedNCT04360655
Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC
A study testing bronchoscopic microwave intervention and anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy in people with Effect Increased and Safety Issues, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
A randomized, prospective study of the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Effect Increased, Safety Issues
- What is being tested?
- bronchoscopic microwave intervention and anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 May 2023
- 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
- advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy
Who cannot join
- contraindications to tracheoscopy, chemotherapy, and immunotherapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Prospective Study of the Efficacy and Safety of the 1st Treatment in Advanced Central NSCLC by PD-1/PD-L1 Inhibitor and Chemotherapy With/Without Bronchoscopic Microwave Intervention
A randomized, prospective study of the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention
Read the detailed description
This study is a randomized, prospective study, which will analyze the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention. The efficacy will include objective response rate, disease control rate, progression-free survival, and overall survival. The safety will include adverse events and quality of life.
- Conditions
- Effect Increased, Safety Issues
- Being tested
- bronchoscopic microwave intervention, anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
- Keywords
- anti-PD-1 / PD-L1 monoclonal antibody, chemotherapy, bronchoscopic microwave intervention, advanced central non-small cell lung cancer patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopic microwave interventionProcedure or surgery
Also called Local treatment
bronchoscopic microwave intervention
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapyDrug
Also called Systemic treatment
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy | Active comparator | anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy Receives: Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy |
| combined with bronchoscopic microwave intervention | Experimental | anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention Receives: Procedure: bronchoscopic microwave intervention; Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
objective response rate
Measured: 6 weeks
progression-free survival
progression-free survival
Measured: 1 years
Secondary outcomes (4)
disease control rate
disease control rate
Measured: 6 weeks
overall survival
overall survival
Measured: 2 years
adverse events
adverse events
Measured: 3 weeks
quality of life score
quality of life score
Measured: World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100，higher scores mean a better outcome.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect IncreasedStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Caicun Zhou, MD, PHD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360655
- Sponsor's protocol ID
- Surpass
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Study of the Efficacy and Safety of the 1st Treatment in Advanced Central NSCLC by PD-1/PD-L1 Inhibitor and Chemotherapy With/Without Bronchoscopic Microwave Intervention
- ClinicalTrials.gov ID
- NCT04360655
- Acronym / sponsor ID
- Surpass
- Conditions
- Effect Increased, Safety Issues
- Keywords
- anti-PD-1 / PD-L1 monoclonal antibody, chemotherapy, bronchoscopic microwave intervention, advanced central non-small cell lung cancer patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 24 Apr 2020 (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.
A randomized, prospective study of the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention
Detailed description
This study is a randomized, prospective study, which will analyze the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention. The efficacy will include objective response rate, disease control rate, progression-free survival, and overall survival. The safety will include adverse events and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy | Active comparator | Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapyanti-PD-1 / PD-L1 monoclonal antibody and chemotherapy |
| combined with bronchoscopic microwave intervention | Experimental | Procedure: bronchoscopic microwave intervention, Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapyanti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy
Key exclusion criteria (1 listed)
- contraindications to tracheoscopy, chemotherapy, and immunotherapy
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 |
|---|---|---|
| bronchoscopic microwave interventionAlso: Local treatmentbronchoscopic microwave intervention | Procedure or surgery | combined with bronchoscopic microwave intervention |
| anti-PD-1 / PD-L1 monoclonal antibody and chemotherapyAlso: Systemic treatmentanti-PD-1 / PD-L1 monoclonal antibody and chemotherapy | Drug | anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy, combined with bronchoscopic microwave intervention |
Primary outcome
objective response rate
Time frame: 6 weeks
objective response rate
progression-free survival
Time frame: 1 years
progression-free survival
4 secondary outcomes
disease control rate
Time frame: 6 weeks
overall survival
Time frame: 2 years
adverse events
Time frame: 3 weeks
quality of life score
Time frame: World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100，higher scores mean a better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Caicun Zhou, MD, PHD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Questions about this trial
What is this clinical trial studying?
A study testing bronchoscopic microwave intervention and anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy in people with Effect Increased and Safety Issues, run by Shanghai Pulmonary Hospital, Shanghai, 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 1 inclusion and 1 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 24 Apr 2020. 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. 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 Yayi He (862165115006 ext. 3056, doctorjael@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 24 Apr 2020.