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To explore the predictive effect of early changes of ctDNA on the efficacy and prognosis of small cell lung cancer (SCLC) immunotherapy based on dynamic monitoring of ctDNA

To explore the predictive effect of early changes of ctDNA on the efficacy and prognosis of small cell lung cancer (SCLC) immunotherapy based on dynamic monitoring of ctDNA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114244
Enrollment
Unknown
Registered
2025-12-09
Start date
2021-08-17
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small cell lung cancer

Interventions

Small cell lung Cancer Observation group:None

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients must meet all the following inclusion criteria to be eligible for this trial: 1. Age between 18 and 75 years old; 2. Patients with ES-SCLC confirmed by pathology through imaging and tumor biopsy; 3. Complete previous pathological information and clinical follow-up information of the patient; 4. Ability to obtain sufficient pre-treatment tumor tissue samples and pre-treatment/post-treatment blood ctDNA for 425-panel sequencing and PD-L1 protein expression detection, and the patient can provide peripheral blood samples as negative controls; 5. The patient's subsequent treatment is planned to use an immunotherapy regimen; 6. The patient's other indicators meet the general inclusion criteria for clinical trials; 7. The participant voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Patients who are not planned to receive an immunotherapy regimen; 2. Patients who, for various reasons, are unable to obtain pre-treatment tumor tissue samples, pre-treatment and post-treatment plasma ctDNA, and whole blood negative control samples. 3. Patients who are unable to obtain follow-up information; 4. Individuals whom the investigator deems unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Correlation between Baseline ctDNA Levels with Patient Immunotherapy Efficacy and Prognosis;

Secondary

MeasureTime frame
Progression-Free Survival ;Overall Survival;Objective Response Rate ;Disease Control Rate ;

Countries

China

Contacts

Public ContactQin Jing

Zhejiang Cancer Hospital

qinjing@zjcc.org.cn+86 571 8812 2092

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026