Multiple Primary Lung CancerPhase 1/2NCT04840758
Stereotactic Ablation Radiotherapy Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer
A Phase 1/2 study testing Stereotactic Ablation Radiotherapy and Sintilimab in people with Multiple Primary Lung Cancer, run by The First Affiliated Hospital of Xiamen University.
Trial summary
The purpose of this study is to assess of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) combined with Sintilimab in early inoperable synchronous Multiple Primary Lung Cancer (sMPLC) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Primary Lung Cancer
- What is being tested?
- Stereotactic Ablation Radiotherapy and Sintilimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Apr 2023
- Phase
- Phase 1/2
- 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
- 1.The diagnostic criteria for early sMPLC refer to the American College of Chest Physicians (ACCP) standard, and the following conditions should be met：
- CT showed the presence of at least three or more lesions（Pure glass or partially solid/solid）
- Proved to be different pathologic types by pathology.
- If there is only one pathologically confirmed lesion or two pathological types are identical, the following conditions need to be met:
- . The lesions are located in different lobes
- . No mediastinal lymph node metastasis
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- . distance metastasis free
- 2. At least two lesions were suitable for SABR treatment.
- 3. ECOG performance status 0-2.
- 4. Stable lab values: Hematological: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) ≤1.5× the upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine levels >1.5× institutional ULN Hepatic: Total bilirubin ≤1.5×ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels >1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN OR ≤5×ULN for patients with liver metastases ,globulin≥20 g/L, albumin≥30 g/L.
- 5. Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study drug if of childbearing potential.
- 6. Able to understand and give written informed consent and comply with study procedures.
Who cannot join
- Previously received any T cell costimulation or immunological checkpoint treatment, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other T cell-targeting drugs.
- An active autoimmune disease requiring systemic treatment (such as the use of disease-alleviating drugs, corticosteroids or immunosuppressants) occurred within 2 years prior to the first administration.Alternative therapies (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic.
- Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction.
- Previous or current history of cancer other than NSCLC, except for non-melanoma skin cancer, in-situ cervical cancer or other cancers that have received curable treatment and have shown no signs of recurrence for at least 5 years.
- Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above.
- There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia.
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- Uncontrolled hypertension after treatment (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90mmHg), with a history of hypertensive crisis or hypertensive encephalopathy;Uncontrolled hyperglycemia after treatment (fasting glucose >8.9mmol/L).
- Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation.
- Active hepatitis B (positive detection of hepatitis B virus surface antigen [HBsAg] in the screening period, and detection of HBV-DNA detection value higher than the upper limit of the normal value of the laboratory in the research center) or hepatitis C (in the screening period, hepatitis C virus surface antibody [ HCsAb] positive, HCV-RNA positive).
- Subjects who have received or will receive live vaccine within 30 days of the first treatment.
- Allergic reactions to test drugs for this application.
- The investigator determined that the subject had other factors that might lead to the termination of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Single-arm Single-center Clinical Study：Assessment of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer (sMPLC)
The purpose of this study is to assess of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) combined with Sintilimab in early inoperable synchronous Multiple Primary Lung Cancer (sMPLC)
Read the detailed description
Stereotactic ablation radiotherapy (SABR) was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor. Immunotherapy was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles.
- Conditions
- Multiple Primary Lung Cancer
- Being tested
- Stereotactic Ablation Radiotherapy, Sintilimab
- Keywords
- Synchronous multiple primary lung cancer, inoperable, Stereotactic ablation radiotherapy, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablation RadiotherapyRadiation
Stereotactic ablation radiotherapy was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor。
SintilimabDrug
Sintilimab was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| SABR+Sintilimab | Experimental | Stereotactic ablation radiotherapy (SABR) was performed sequentially on the primary and secondary lesions. Sintilimab was used 2 weeks after the end of SABR. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles. Receives: Radiation: Stereotactic Ablation Radiotherapy; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
abscopal effect rate
A reaction produced following irradiation but occurring outside the zone of actual radiation absorption
Measured: at the time point of 3 Months after completion of the combined treatment
Secondary outcomes (3)
Incidence of Adverse events
AE，according to NCI-CTCAE V4.03 and immune-related (ir) RECIST
Measured: up to approximately 1 year
Progression-Free Survival (PFS)
PFS, defined as the time from treatment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Measured: up to approximately 1 year
Disease Control Rate (DCR)
Disease Control Rate（DCR） according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
Measured: up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study startJun 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Primary Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiang jie, MD, Principal investigator, First affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840758
- Sponsor's protocol ID
- XMYY-2020Y091
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 12 Apr 2021
- Results posted
- 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 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm Single-center Clinical Study：Assessment of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer (sMPLC)
- ClinicalTrials.gov ID
- NCT04840758
- Acronym / sponsor ID
- XMYY-2020Y091
- Conditions
- Multiple Primary Lung Cancer
- Keywords
- Synchronous multiple primary lung cancer, inoperable, Stereotactic ablation radiotherapy, Sintilimab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 12 Apr 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.
The purpose of this study is to assess of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) combined with Sintilimab in early inoperable synchronous Multiple Primary Lung Cancer (sMPLC)
Detailed description
Stereotactic ablation radiotherapy (SABR) was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor. Immunotherapy was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SABR+Sintilimab | Experimental | Radiation: Stereotactic Ablation Radiotherapy, Drug: SintilimabStereotactic ablation radiotherapy (SABR) was performed sequentially on the primary and secondary lesions. Sintilimab was used 2 weeks after the end of SABR. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1.The diagnostic criteria for early sMPLC refer to the American College of Chest Physicians (ACCP) standard, and the following conditions should be met：
- CT showed the presence of at least three or more lesions（Pure glass or partially solid/solid）
- Proved to be different pathologic types by pathology.
- If there is only one pathologically confirmed lesion or two pathological types are identical, the following conditions need to be met:
- . The lesions are located in different lobes
Key exclusion criteria (12 listed)
- Previously received any T cell costimulation or immunological checkpoint treatment, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other T cell-targeting drugs.
- An active autoimmune disease requiring systemic treatment (such as the use of disease-alleviating drugs, corticosteroids or immunosuppressants) occurred within 2 years prior to the first administration.Alternative therapies (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic.
- Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction.
- Previous or current history of cancer other than NSCLC, except for non-melanoma skin cancer, in-situ cervical cancer or other cancers that have received curable treatment and have shown no signs of recurrence for at least 5 years.
- Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above.
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 |
|---|---|---|
| Stereotactic Ablation RadiotherapyStereotactic ablation radiotherapy was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor。 | Radiation | SABR+Sintilimab |
| SintilimabSintilimab was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles | Drug | SABR+Sintilimab |
Primary outcome
abscopal effect rate
Time frame: at the time point of 3 Months after completion of the combined treatment
A reaction produced following irradiation but occurring outside the zone of actual radiation absorption
3 secondary outcomes
Incidence of Adverse events
Time frame: up to approximately 1 year
Progression-Free Survival (PFS)
Time frame: up to approximately 1 year
Disease Control Rate (DCR)
Time frame: up to approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- 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.
Jiang jie, MD principal investigator
First affiliated Hospital of Xiamen University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic Ablation Radiotherapy and Sintilimab in people with Multiple Primary Lung Cancer, run by The First Affiliated Hospital of Xiamen University.
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 12 inclusion and 12 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 12 Apr 2021. 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.
What does this combined 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.
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 Deng Chong, MD (8605922139531, dengchongxm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abscopal effect rate (time frame: at the time point of 3 Months after completion of the combined treatment). 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 12 Apr 2021.