NCT07244016Recruiting
Clinical Study on Using TCR to Predict the Effect of Tislelizumab + Chemotherapy in the First-line Treatment of ES-SCLC
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
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 8 May 2025
- Start date
- 20 Feb 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Henan Cancer Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07244016
What you commit to
- Study type: Observational
- Planned participants: 40
- From 20 Feb 2025 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- 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
- Other circumstances as determined by the investigator.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan Cancer Hosipital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.