NeoplasmsPhase 2GALAXY-1NCT05964101
Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
A Phase 2 study testing Nivolumab Injection [Opdivo] in people with Neoplasms and Carcinoma, Squamous, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoplasms, Carcinoma, Squamous, Antineoplastic Agents
- What is being tested?
- Nivolumab Injection [Opdivo]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 May 2026
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bronchoscopic biopsy confirmed as tracheal squamous cell carcinoma by pathological examination
- PET-CT confirmed no metastasis;
- ECOG physical status score 0-1;
- Bronchoscopy, and chest CT is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy.
- Age ≥ 18 years;
- Have one measurable lesion at least;
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- Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be < 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN
- Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after chemotherapy or the last administration of Nivolumab, whichever is later, and the urine or serum pregnancy test results less than 7 days before entering the group were negative. Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after chemotherapy or the last administration of Nivolumab, whichever is the latter.
- Sign informed consent;
Who cannot join
- Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug;
- Patients with other malignant tumors in the five years before the start of this trial.
- Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;
- Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
- A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
- Had is suffering from nephrotic syndrome
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- Allergic to experimental drugs;
- Complicated with HIV infection or active hepatitis.
- Vaccination within 4 weeks before the start of this trial;
- Those who had undergone other major operations or severe injuries within the previous 2 months;
- Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;
- Pregnant or lactating women;
- Those with neurological diseases or mental disorders.
- Participated in another therapeutic clinical study at the same time;
- Other researchers did not consider it appropriate to enroll in the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Shuben Li, Doctor, 13500030280@163.com
About this study
Official title: Neoadjuvant Anti-PD-1 Drug Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.
Read the detailed description
Primary tracheal tumors are rare, comprising 0.01-0.4% of all cancer cases. Most airway tumors present with non-specific symptoms, such as shortness of breath and a sore throat, which may not be attributable to the tumors themselves, leading to diagnostic delay. With limited treatment options, surgical resection is considered the cornerstone therapy. Neoadjuvant therapy is recommended as standard treatment for the early stages (stage IB/II) and locally advanced stages (stage IIIA) of non-small cell lung cancer (NSCLC). Whether neoadjuvant therapy affects subsequent pathological or surgical outcomes of primary tracheal tumors remains unclear. This study aimed to characterize the outcomes of neoadjuvant therapy for the treatment of primary tracheal squamous cell carcinoma.
- Conditions
- Neoplasms, Carcinoma, Squamous, Antineoplastic Agents
- Being tested
- Nivolumab Injection [Opdivo]
- Keywords
- tracheal tumor, neoadjuvant immunochemotherapy, surgery
- Medical subject headings
- Neoplasms, Carcinoma, Squamous Cell, Tracheal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab Injection [Opdivo]Drug
Also called carboplatin, paclitaxel
Neoadjuvant treatment stage: Nivolumab +Carboplatin AUC+ paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Neoadjuvant treatment stage: Nivolumab 360mg, Carboplatin AUC5+ paclitaxel 100 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with primary tracheal squamous cell carcinoma received radical surgery after neoadjuvant therapy, and patients who could not or refused surgical treatment due to various reasons were treated with multidisciplinary discussion. Receives: Drug: Nivolumab Injection [Opdivo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Measured: up to 4 months
Safety: frequency of severe adverse events
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Measured: up to 5 months
Secondary outcomes (5)
Progression-free survival (PFS)
PFS is defined as the time from the enrollment of the subject to the first determination of disease progression or death of any cause according to RECISTv1.1, whichever occurs first.
Measured: up to 24 months
Overall survival (OS)
It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).
Measured: up to 60 months
Disease control rate (DCR)
The proportion of patients whose best overall remission (BOR) is CR, PR or disease stable (SD) according to RECISTv1.1 evaluation
Measured: up to 60 months
Duration of remission (DOR)
According to the time from the first recording of objective remission to relapse or death from any cause determined by RECISTv1.1, whichever occurs first.
Measured: up to 60 months
R0 rate
There were no visible tumors in the surgical margin, and the tumor cells in the surgical margin within 1mm were negative under the microscope
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Oct 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuben Li, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Shuben Li, PhD, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964101
- Sponsor's protocol ID
- ES-2023-062-03
- Acronym
- GALAXY-1
- Status last verified
- May 2024
- First submitted
- 12 Jul 2023
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Anti-PD-1 Drug Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05964101
- Acronym / sponsor ID
- GALAXY-1 / ES-2023-062-03
- Conditions
- Neoplasms, Carcinoma, Squamous, Antineoplastic Agents
- Keywords
- tracheal tumor, neoadjuvant immunochemotherapy, surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 27 Jul 2023 (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.
This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.
Detailed description
Primary tracheal tumors are rare, comprising 0.01-0.4% of all cancer cases. Most airway tumors present with non-specific symptoms, such as shortness of breath and a sore throat, which may not be attributable to the tumors themselves, leading to diagnostic delay. With limited treatment options, surgical resection is considered the cornerstone therapy. Neoadjuvant therapy is recommended as standard treatment for the early stages (stage IB/II) and locally advanced stages (stage IIIA) of non-small cell lung cancer (NSCLC). Whether neoadjuvant therapy affects subsequent pathological or surgical outcomes of primary tracheal tumors remains unclear. This study aimed to characterize the outcomes of neoadjuvant therapy for the treatment of primary tracheal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: Nivolumab Injection [Opdivo]Neoadjuvant treatment stage: Nivolumab 360mg, Carboplatin AUC5+ paclitaxel 100 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with primary tracheal squamous cell carcinoma received radical surgery after neoadjuvant therapy, and patients who could not or refused surgical treatment due to various reasons were treated with multidisciplinary discussion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bronchoscopic biopsy confirmed as tracheal squamous cell carcinoma by pathological examination
- PET-CT confirmed no metastasis;
- ECOG physical status score 0-1;
- Bronchoscopy, and chest CT is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy.
- Age ≥ 18 years;
Key exclusion criteria (15 listed)
- Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug;
- Patients with other malignant tumors in the five years before the start of this trial.
- Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;
- Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
- A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
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 |
|---|---|---|
| Nivolumab Injection [Opdivo]Also: carboplatin, paclitaxelNeoadjuvant treatment stage: Nivolumab +Carboplatin AUC+ paclitaxel | Drug | Nivolumab |
Primary outcome
Major pathologic response (MPR)
Time frame: up to 4 months
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Safety: frequency of severe adverse events
Time frame: up to 5 months
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 24 months
Overall survival (OS)
Time frame: up to 60 months
Disease control rate (DCR)
Time frame: up to 60 months
Duration of remission (DOR)
Time frame: up to 60 months
R0 rate
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Shuben Li, PhD study chair
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab Injection [Opdivo] in people with Neoplasms and Carcinoma, Squamous, run by The First Affiliated Hospital of Guangzhou Medical University 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 15 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 21 May 2024. 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.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuben Li, PhD (+8613500030280, 13500030280@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (MPR) (time frame: up to 4 months). 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 21 May 2024.