OligometastasisPhase 2NCT04486287
Sintilimab After Stereotactic Ablation Brachytherapy for Refractory Oligometastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Sintilimab in people with Oligometastasis and Lung Neoplasms, run by Tianjin Medical University Second Hospital.
Trial summary
The study aim to investigator the efficacy and safety of sintilimab after Stereotactic Ablation Brachytherapy(SABT) for refractory oligometastatic non-small cell lung cancer(NSCLC), who had failed second-line systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastasis, Lung Neoplasms
- What is being tested?
- Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Provide written informed consent for the trial.
- 2.18 years of age on day of signing informed consent.
- 3.Completion of definitive therapy 4-12 weeks prior to enrollment. There are no specific limitations on which treatment modalities can be used in the definitive setting (e.g. the use of adjuvant chemotherapy is acceptable), but all other treatments must be complete at least 4 weeks prior to enrollment.
- 4.Patients confirmed by histological specimens who are not eligible for EGFR, ALK or ROS1 targeted therapy (with no tumor) EGFR-sensitive mutations and no evidence of ALK, ROS1 gene rearrangement.
- 5.Patients must have disease progression or recurrence after receiving first line systemic therapy for advanced or metastasis disease: 1) Maintenance therapy after platinum based chemo-doublet shall not be considered as a separated treatment regimen, 2)Patients who had received neo-adjuvant/adjuvant therapy or radical chemo- radiotherapy for local advanced disease and relapsed after 6 month or later, must have failed second-line treatment for recurrent disease before enrollment.
- 6.ECOG PS 0-2, with expected survival over 3 months.
Show all 13Show fewer
- 7.Adequate hematopoietic function, defined as: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count ≥100 x 109/L; hemoglobin ≥90 g/L [no blood transfusion within 7 days or not erythropoietin (EPO) dependent].
- 8.Adequate liver function, defined as: total serum bilirubin ≤ 1.5 x upper limit of normal (ULN); serum alanine transaminase (ALT) and aspartic transaminase (AST) ≤ 2.5 x ULN, with no liver transplantation.
- 9.Adequate renal function, defined as: serum creatinine ≤ 1.5 x ULN or calculated creatinine-clearance ≥ 60 ml/min (Cockcroft-Gault). Urine protein less than 2+ by urinalysis or 24-hour urinary protein quantity < 1g.
- 10.Adequate coagulation function, defined as: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN. For patients receiving anticoagulant therapy can be enrolled if PT is within the range defined by anticoagulant therapy.
- 11.Myocardial enzymes are within normal range.
- 12.For all female patients of childbearing potential, a negative pregnancy test (either urine or serum) must be obtained within 3 days before the first dose (Cycle 1, Day 1) of study treatment. If a urine pregnancy test shows an unconfirmed result, a serum pregnancy test must be performed.
- 13.All subjects of childbearing potential must agree to use efficient contraceptive methods that result in a failure rate of < 1% per year during the study treatment period and for at least 180 days after discontinuation from study treatment.
Who cannot join
- Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Diagnosis of immunodeficiency or exposure to systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (Nasal or oral inhalers are permissible).
- Prior monoclonal antibody within 4 weeks prior to study Day 1 or individuals who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 drug administration on study or inability to recover (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Subjects with ≤ Grade 2 neuropathy or alopecia are exceptions to this criterion and may qualify for the study.
- Note: If subject had major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Show all 20Show fewer
- Known additional malignancy that is progressing or requires active treatment.
- Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-invasive bladder tumors, or in situ cervical cancer
- Known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule.Subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome are not excluded from the study.
- Evidence of pre-existing interstitial lung disease or active, non-infectious pneumonitis.
- Active infection requiring systemic therapy with IV antibiotics
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Known active Hepatitis B (e.g., HBsAg positive or HBV DNA detectable) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Receipt of live vaccine within 30 days prior to the first dose of trial treatment.
- Progressive disease or sites of new metastasis after definitive therapy for oligometastatic disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II Study of PD-1 Inhibitor With Sintilimab After Stereotactic Ablation Brachytherapy for Refractory Oligometastatic Non-Small Cell Lung Cancer
The study aim to investigator the efficacy and safety of sintilimab after Stereotactic Ablation Brachytherapy(SABT) for refractory oligometastatic non-small cell lung cancer(NSCLC), who had failed second-line systemic therapy.
Read the detailed description
This study is a single-arm phase II study of sintilimab after SABT for refractory oligometastatic NSCLC, who had failed second-line systemic therapy.In this study, 44 patients with oligometastatic NSCLC were treated with sintilimab after SABT every 3 weeks until disease progression and intolerance. Toxicity, withdrawal of informed consent, death or other cessation of treatment as prescribed by the program, whichever occurs first. The primary end point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review Board (IRRC). An interim analysis will be conducted during the course of the study. The results and reports will be provided to the Independent Data Audit Committee (IDMC), which determines whether the trial is valid based on the valid cut-off value of the trial and whether the study data can be submitted in advance. Make recommendations to the sponsor. Prior to the interim analysis, the IDMC charter will be finalized and approved by IDMC and the sponsor. The responsibilities and related procedures of IDMC members will be defined in the IDMC charter.
- Conditions
- Oligometastasis, Lung Neoplasms
- Being tested
- Sintilimab
- Keywords
- PD-1 inhibitor,Brachytherapy,SABT,Oligometastatic,NSCLC
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called Tyvyt, IBI 308
Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 12 months.
Before enrollment, patient should undergo Stereotactic Ablation Brachytherapy. Sintilimab shall be started no later than 4 weeks after Stereotactic Ablation Brachytherapy.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab Arm | Experimental | Sintilimab after Stereotactic Ablation Brachytherapy. Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR(RECIST 1.1 as assessed by the investigator )is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best response.
Measured: up to 24 months after enrollment or study close.
Secondary outcomes (4)
Progression-free survival (PFS)
Time to progression or death from initiation of Stereotactic Ablation Brachytherapy.
Measured: up to 24 months after enrollment or study close.
Overall Survival(OS)
Defined as the time until death due to any cause.
Measured: up to 24 months after enrollment or study close.
Disease Control Rate (DCR)
RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).
Measured: up to 24 months after enrollment or study close .
Treatment-related Adverse Events (AEs)
Evaluation of adverse event rate according to CTCAE(Common terminology criteria for adverse events) v4.03.
Measured: From the date of randomization to 90 days after last dose of study treatment .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for OligometastasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BIN HUO, Principal investigator, Tianjin Medical Unversity Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486287
- Sponsor's protocol ID
- SA-SABT
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergsma DP, Salama JK, Singh DP, Chmura SJ, Milano MT. Radiotherapy for Oligometastatic Lung Cancer. Front Oncol. 2017 Sep 19;7:210. doi: 10.3389/fonc.2017.00210. eCollection 2017.
PubMed 28975081Gong HY, Wang Y, Han G, Song QB. Radiotherapy for oligometastatic tumor improved the prognosis of patients with non-small cell lung cancer (NSCLC). Thorac Cancer. 2019 May;10(5):1136-1140. doi: 10.1111/1759-7714.13054. Epub 2019 Apr 7.
PubMed 30957423Punnanitinont A, Kannisto ED, Matsuzaki J, Odunsi K, Yendamuri S, Singh AK, Patnaik SK. Sublethal Radiation Affects Antigen Processing and Presentation Genes to Enhance Immunogenicity of Cancer Cells. Int J Mol Sci. 2020 Apr 7;21(7):2573. doi: 10.3390/ijms21072573.
PubMed 32272797Shevtsov M, Sato H, Multhoff G, Shibata A. Novel Approaches to Improve the Efficacy of Immuno-Radiotherapy. Front Oncol. 2019 Mar 19;9:156. doi: 10.3389/fonc.2019.00156. eCollection 2019.
PubMed 30941308Bauml JM, Mick R, Ciunci C, Aggarwal C, Davis C, Evans T, Deshpande C, Miller L, Patel P, Alley E, Knepley C, Mutale F, Cohen RB, Langer CJ. Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non-Small Cell Lung Cancer: A Phase 2 Trial. JAMA Oncol. 2019 Sep 1;5(9):1283-1290. doi: 10.1001/jamaoncol.2019.1449.
PubMed 31294762Theelen WSME, Peulen HMU, Lalezari F, van der Noort V, de Vries JF, Aerts JGJV, Dumoulin DW, Bahce I, Niemeijer AN, de Langen AJ, Monkhorst K, Baas P. Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Sep 1;5(9):1276-1282. doi: 10.1001/jamaoncol.2019.1478.
PubMed 31294749Annede P, Cosset JM, Van Limbergen E, Deutsch E, Haie-Meder C, Chargari C. Radiobiology: Foundation and New Insights in Modeling Brachytherapy Effects. Semin Radiat Oncol. 2020 Jan;30(1):4-15. doi: 10.1016/j.semradonc.2019.08.009.
PubMed 31727299Gao S, Li N, Gao S, Xue Q, Ying J, Wang S, Tao X, Zhao J, Mao Y, Wang B, Shao K, Lei W, Wang D, Lv F, Zhao L, Zhang F, Zhao Z, Su K, Tan F, Gao Y, Sun N, Wu D, Yu Y, Ling Y, Wang Z, Duan C, Tang W, Zhang L, He S, Wu N, Wang J, He J. Neoadjuvant PD-1 inhibitor (Sintilimab) in NSCLC. J Thorac Oncol. 2020 May;15(5):816-826. doi: 10.1016/j.jtho.2020.01.017. Epub 2020 Feb 6.
PubMed 32036071
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of PD-1 Inhibitor With Sintilimab After Stereotactic Ablation Brachytherapy for Refractory Oligometastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04486287
- Acronym / sponsor ID
- SA-SABT
- Conditions
- Oligometastasis, Lung Neoplasms
- Keywords
- PD-1 inhibitor,Brachytherapy,SABT,Oligometastatic,NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 24 Jul 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.
The study aim to investigator the efficacy and safety of sintilimab after Stereotactic Ablation Brachytherapy(SABT) for refractory oligometastatic non-small cell lung cancer(NSCLC), who had failed second-line systemic therapy.
Detailed description
This study is a single-arm phase II study of sintilimab after SABT for refractory oligometastatic NSCLC, who had failed second-line systemic therapy.In this study, 44 patients with oligometastatic NSCLC were treated with sintilimab after SABT every 3 weeks until disease progression and intolerance. Toxicity, withdrawal of informed consent, death or other cessation of treatment as prescribed by the program, whichever occurs first. The primary end point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review Board (IRRC). An interim analysis will be conducted during the course of the study. The results and reports will be provided to the Independent Data Audit Committee (IDMC), which determines whether the trial is valid based on the valid cut-off value of the trial and whether the study data can be submitted in advance. Make recommendations to the sponsor. Prior to the interim analysis, the IDMC charter will be finalized and approved by IDMC and the sponsor. The responsibilities and related procedures of IDMC members will be defined in the IDMC charter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab Arm | Experimental | Drug: SintilimabSintilimab after Stereotactic Ablation Brachytherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1.Provide written informed consent for the trial.
- 2.18 years of age on day of signing informed consent.
- 3.Completion of definitive therapy 4-12 weeks prior to enrollment. There are no specific limitations on which treatment modalities can be used in the definitive setting (e.g. the use of adjuvant chemotherapy is acceptable), but all other treatments must be complete at least 4 weeks prior to enrollment.
- 4.Patients confirmed by histological specimens who are not eligible for EGFR, ALK or ROS1 targeted therapy (with no tumor) EGFR-sensitive mutations and no evidence of ALK, ROS1 gene rearrangement.
- 5.Patients must have disease progression or recurrence after receiving first line systemic therapy for advanced or metastasis disease: 1) Maintenance therapy after platinum based chemo-doublet shall not be considered as a separated treatment regimen, 2)Patients who had received neo-adjuvant/adjuvant therapy or radical chemo- radiotherapy for local advanced disease and relapsed after 6 month or later, must have failed second-line treatment for recurrent disease before enrollment.
Key exclusion criteria (20 listed)
- Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Diagnosis of immunodeficiency or exposure to systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (Nasal or oral inhalers are permissible).
- Prior monoclonal antibody within 4 weeks prior to study Day 1 or individuals who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 drug administration on study or inability to recover (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Subjects with ≤ Grade 2 neuropathy or alopecia are exceptions to this criterion and may qualify for the study.
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 |
|---|---|---|
| SintilimabAlso: Tyvyt, IBI 308Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 12 months. Before enrollment, patient should undergo Stereotactic Ablation Brachytherapy. Sintilimab shall be started no later than 4 weeks after Stereotactic Ablation Brachytherapy. | Drug | Sintilimab Arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 24 months after enrollment or study close.
ORR(RECIST 1.1 as assessed by the investigator )is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best response.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 24 months after enrollment or study close.
Overall Survival(OS)
Time frame: up to 24 months after enrollment or study close.
Disease Control Rate (DCR)
Time frame: up to 24 months after enrollment or study close .
Treatment-related Adverse Events (AEs)
Time frame: From the date of randomization to 90 days after last dose of study treatment .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Background: PubMed 28975081Bergsma DP, Salama JK, Singh DP, Chmura SJ, Milano MT. Radiotherapy for Oligometastatic Lung Cancer. Front Oncol. 2017 Sep 19;7:210. doi: 10.3389/fonc.2017.00210. eCollection 2017.
- Background: PubMed 30957423Gong HY, Wang Y, Han G, Song QB. Radiotherapy for oligometastatic tumor improved the prognosis of patients with non-small cell lung cancer (NSCLC). Thorac Cancer. 2019 May;10(5):1136-1140. doi: 10.1111/1759-7714.13054. Epub 2019 Apr 7.
- Background: PubMed 32272797Punnanitinont A, Kannisto ED, Matsuzaki J, Odunsi K, Yendamuri S, Singh AK, Patnaik SK. Sublethal Radiation Affects Antigen Processing and Presentation Genes to Enhance Immunogenicity of Cancer Cells. Int J Mol Sci. 2020 Apr 7;21(7):2573. doi: 10.3390/ijms21072573.
- Background: PubMed 30941308Shevtsov M, Sato H, Multhoff G, Shibata A. Novel Approaches to Improve the Efficacy of Immuno-Radiotherapy. Front Oncol. 2019 Mar 19;9:156. doi: 10.3389/fonc.2019.00156. eCollection 2019.
- Background: PubMed 31294762Bauml JM, Mick R, Ciunci C, Aggarwal C, Davis C, Evans T, Deshpande C, Miller L, Patel P, Alley E, Knepley C, Mutale F, Cohen RB, Langer CJ. Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non-Small Cell Lung Cancer: A Phase 2 Trial. JAMA Oncol. 2019 Sep 1;5(9):1283-1290. doi: 10.1001/jamaoncol.2019.1449.
- Background: PubMed 31294749Theelen WSME, Peulen HMU, Lalezari F, van der Noort V, de Vries JF, Aerts JGJV, Dumoulin DW, Bahce I, Niemeijer AN, de Langen AJ, Monkhorst K, Baas P. Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Sep 1;5(9):1276-1282. doi: 10.1001/jamaoncol.2019.1478.
- Background: PubMed 31727299Annede P, Cosset JM, Van Limbergen E, Deutsch E, Haie-Meder C, Chargari C. Radiobiology: Foundation and New Insights in Modeling Brachytherapy Effects. Semin Radiat Oncol. 2020 Jan;30(1):4-15. doi: 10.1016/j.semradonc.2019.08.009.
- Background: PubMed 32036071Gao S, Li N, Gao S, Xue Q, Ying J, Wang S, Tao X, Zhao J, Mao Y, Wang B, Shao K, Lei W, Wang D, Lv F, Zhao L, Zhang F, Zhao Z, Su K, Tan F, Gao Y, Sun N, Wu D, Yu Y, Ling Y, Wang Z, Duan C, Tang W, Zhang L, He S, Wu N, Wang J, He J. Neoadjuvant PD-1 inhibitor (Sintilimab) in NSCLC. J Thorac Oncol. 2020 May;15(5):816-826. doi: 10.1016/j.jtho.2020.01.017. Epub 2020 Feb 6.
- Individual participant dataSharing planned: No
Related trials for Oligometastasis
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
RecruitingObservational study
Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma, Lung Cancer
RecruitingPhase 2
Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.
Colorectal Neoplasms Malignant
RecruitingPhase 3
Metastasis-directed Therapy for Oligometastases of Breast Cancer
Breast Cancer, Oligometastasis
RecruitingPhase 2
Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
Gastric Adenocarcinoma, Oligometastasis
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.
BIN HUO principal investigator
Tianjin Medical Unversity Second Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab in people with Oligometastasis and Lung Neoplasms, run by Tianjin Medical University Second Hospital.
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 13 inclusion and 20 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 Jul 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.
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 BIN HUO, MD (+86-022-88326791, chengzi123123@163.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: up to 24 months after enrollment or study close.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486287, which also lists 8 linked publications.
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 Jul 2020.