NCT07244016 Clinical Study on Using TCR to Predict the Effect of Tislelizumab + Chemotherapy in the First-line Treatment of ES-SCLC
| NCT ID | NCT07244016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henan Cancer Hospital |
| Condition | Extensive-stage Small-cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-02-20 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Henan Province Cancer Hospital Ethics Committee Henan Province Cancer Hospital Ethics Committee
✉ dingjing201305@163.com📞 0371-65588251
Chen Li Juan, Prof
PRINCIPAL INVESTIGATOR
Henan Cancer Hospital
Frequently Asked Questions
Who can join the NCT07244016 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extensive-stage Small-cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07244016 currently recruiting?
Yes, NCT07244016 is actively recruiting participants. Contact the research team at dingjing201305@163.com for enrollment information.
Where is the NCT07244016 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT07244016 clinical trial?
NCT07244016 is sponsored by Henan Cancer Hospital. The principal investigator is Chen Li Juan, Prof at Henan Cancer Hospital. The trial plans to enroll 40 participants.
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