Extensive-stage Small-cell Lung CancerES-SCLCNCT07244016
Clinical Study on Using TCR to Predict the Effect of Tislelizumab + Chemotherapy in the First-line Treatment of ES-SCLC
An observational study of Extensive-stage Small-cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a prospective observational clinical study designed to predict the therapeutic efficacy of first-line treatment with tislelizumab combined with standard chemotherapy in patients with ES-SCLC using TCR repertoire technology. The study plans to enroll 40 treatment-naive patients with ES-SCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Histologically proven ES-SCLC (American Joint Cancer Commission (7th Edition) Stage IV SCLC [any T, any N and M1a/b]), or T3-4 patients who are unable to be included in a tolerable radiotherapy program due to wide multiple incidences or excessive tumor volume.
Who may be able to join
- Histologically proven ES-SCLC (American Joint Cancer Commission (7th Edition) Stage IV SCLC [any T, any N and M1a/b]), or T3-4 patients who are unable to be included in a tolerable radiotherapy program due to wide multiple incidences or excessive tumor volume.
- Patients with brain metastases must have asymptomatic or stable steroid and anticonvulsant treatment for at least 1 month before study treatment. Patients with suspected brain metastasis during screening should undergo brain CT/MRI examination before enrollment of the study.
- Have at least one measurable tumour lesion according to RECIST v1.1.
- aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1
Who cannot join
- Have a history of chest radiotherapy or plan to undergo intensive chest radiotherapy before systemic treatment. Radiotherapy outside the chest (i.e., bone metastasis) is allowed for palliative care purposes, however, must be done before the first medication of the study drug
- Previous non-infectious pneumonia requiring systemic glucocorticoid therapy or current non-infectious pneumonia combined with mild to moderate interstitial pneumonia, inactive interstitial pneumonia.
- Presence of unmitigated toxicity from prior antineoplastic therapy, with unmitigated defined as failure to recover to NCI CTCAE version 5.0 grade 0 or 1 (except alopecia areata) or failure to recover to levels specified in the inclusion/exclusion criteria.
- History of known allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation; history of organ or haematopoietic stem cell transplantation requiring immunosuppression.
- Patients with chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA ≥500 IU/mL (2500 copies/mL), or hepatitis C patients.
- Other circumstances as determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Henan Province Cancer Hospital Ethics Committee Henan Province Cancer Hospital Ethics Committee contact
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hosipital
Zhengzhou, Henan, 450000
Chen Lijuan Chen Lijuan, 0371-65588251, hnszlyyyb@163.com
About this study
Official title: Clinical Study on Using T Cell Repertoire Technology to Predict the Therapeutic Effect of Tislelizumab + Standard Chemotherapy in the First-line Treatment of Extensive-stage Small Cell Lung Cancer
This is a prospective observational clinical study designed to predict the therapeutic efficacy of first-line treatment with tislelizumab combined with standard chemotherapy in patients with ES-SCLC using TCR repertoire technology. The study plans to enroll 40 treatment-naive patients with ES-SCLC.
Read the detailed description
The advancement of Next-Generation Sequencing (NGS) technology has facilitated the detection of T-cell immune repertoires across various solid tumor types, and a growing body of research indicates that T-cell immune repertoires hold potential as biomarkers for immunotherapy; in the field of non-small cell lung cancer (NSCLC), previous studies have suggested that the characteristics of the baseline T-cell receptor (TCR) repertoire and changes in the TCR repertoire before and after immunotherapy are associated with immunotherapeutic efficacy, while such exploration remains lacking in the field of small cell lung cancer (SCLC). Due to limitations in cost and experimental methods, the currently available TCR databases contain limited information, encompassing only a small fraction of antigen-TCR binding pairs, and furthermore, these binding pair data fail to cover all antigens that any given TCR might potentially bind to; to address this issue, the research community has explored the use of machine learning models to predict the antigen specificity of unknown and experimentally unvalidated TCRs, which has shown feasibility. This study, as a prospective observational clinical study designed to predict the therapeutic efficacy of first-line treatment with tislelizumab combined with standard chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC) using TCR repertoire technology, plans to enroll 40 treatment-naive patients with ES-SCLC, and aims to predict the neoantigen-specific TCR repertoire by analyzing tumor neoantigens, integrating T-cell repertoire data and HLA class I detection information, and leveraging the Multimodal-AIR-BERT machine learning model, with the hypothesis that the parameters of this predicted TCR repertoire may exhibit a stronger correlation with immunotherapeutic efficacy.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free survival time
Time from enrollment to either radiological progression or death
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Feb 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chen Li Juan, Prof, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244016
- Sponsor's protocol ID
- HXNY-TI-001
- Acronym
- ES-SCLC
- Status last verified
- Feb 2025
- First submitted
- 8 May 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Using T Cell Repertoire Technology to Predict the Therapeutic Effect of Tislelizumab + Standard Chemotherapy in the First-line Treatment of Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07244016
- Acronym / sponsor ID
- ES-SCLC / HXNY-TI-001
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 24 Nov 2025 (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 prospective observational clinical study designed to predict the therapeutic efficacy of first-line treatment with tislelizumab combined with standard chemotherapy in patients with ES-SCLC using TCR repertoire technology. The study plans to enroll 40 treatment-naive patients with ES-SCLC.
Detailed description
The advancement of Next-Generation Sequencing (NGS) technology has facilitated the detection of T-cell immune repertoires across various solid tumor types, and a growing body of research indicates that T-cell immune repertoires hold potential as biomarkers for immunotherapy; in the field of non-small cell lung cancer (NSCLC), previous studies have suggested that the characteristics of the baseline T-cell receptor (TCR) repertoire and changes in the TCR repertoire before and after immunotherapy are associated with immunotherapeutic efficacy, while such exploration remains lacking in the field of small cell lung cancer (SCLC). Due to limitations in cost and experimental methods, the currently available TCR databases contain limited information, encompassing only a small fraction of antigen-TCR binding pairs, and furthermore, these binding pair data fail to cover all antigens that any given TCR might potentially bind to; to address this issue, the research community has explored the use of machine learning models to predict the antigen specificity of unknown and experimentally unvalidated TCRs, which has shown feasibility. This study, as a prospective observational clinical study designed to predict the therapeutic efficacy of first-line treatment with tislelizumab combined with standard chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC) using TCR repertoire technology, plans to enroll 40 treatment-naive patients with ES-SCLC, and aims to predict the neoantigen-specific TCR repertoire by analyzing tumor neoantigens, integrating T-cell repertoire data and HLA class I detection information, and leveraging the Multimodal-AIR-BERT machine learning model, with the hypothesis that the parameters of this predicted TCR repertoire may exhibit a stronger correlation with immunotherapeutic efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically proven ES-SCLC (American Joint Cancer Commission (7th Edition) Stage IV SCLC [any T, any N and M1a/b]), or T3-4 patients who are unable to be included in a tolerable radiotherapy program due to wide multiple incidences or excessive tumor volume.
Key inclusion criteria (5 listed)
- Histologically proven ES-SCLC (American Joint Cancer Commission (7th Edition) Stage IV SCLC [any T, any N and M1a/b]), or T3-4 patients who are unable to be included in a tolerable radiotherapy program due to wide multiple incidences or excessive tumor volume.
- Patients with brain metastases must have asymptomatic or stable steroid and anticonvulsant treatment for at least 1 month before study treatment. Patients with suspected brain metastasis during screening should undergo brain CT/MRI examination before enrollment of the study.
- Have at least one measurable tumour lesion according to RECIST v1.1.
- aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1
Key exclusion criteria (6 listed)
- Have a history of chest radiotherapy or plan to undergo intensive chest radiotherapy before systemic treatment. Radiotherapy outside the chest (i.e., bone metastasis) is allowed for palliative care purposes, however, must be done before the first medication of the study drug
- Previous non-infectious pneumonia requiring systemic glucocorticoid therapy or current non-infectious pneumonia combined with mild to moderate interstitial pneumonia, inactive interstitial pneumonia.
- Presence of unmitigated toxicity from prior antineoplastic therapy, with unmitigated defined as failure to recover to NCI CTCAE version 5.0 grade 0 or 1 (except alopecia areata) or failure to recover to levels specified in the inclusion/exclusion criteria.
- History of known allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation; history of organ or haematopoietic stem cell transplantation requiring immunosuppression.
- Patients with chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA ≥500 IU/mL (2500 copies/mL), or hepatitis C patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progress-free survival time
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Time from enrollment to either radiological progression or death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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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.
Henan Province Cancer Hospital Ethics Committee Henan Province Cancer Hospital Ethics Committee contact
Chen Li Juan, Prof principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extensive-stage Small-cell Lung Cancer, run by Henan Cancer 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 5 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henan Province Cancer Hospital Ethics Committee Henan Province Cancer Hospital Ethics Committee (0371-65588251, dingjing201305@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-free survival time (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). 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 Nov 2025.