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Application of cfDNA epigenetic multi-omics to predict the response of lung cancer immune checkpoint inhibitors

Application of cfDNA epigenetic multi-omics to predict the response of lung cancer immune checkpoint inhibitors

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043315
Enrollment
Unknown
Registered
2021-02-10
Start date
2021-03-15
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Non-small cell lung cancer

Interventions

case series:Nil

Sponsors

Cancer Hospital of Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-75 at the time of signing the informed consent; 2. Subjects with negative EGFR / ALK gene and unresectable NSCLC of limited or extensive stage confirmed by histopathology or cytology; 3. Subjects who have not received immune checkpoint therapy drugs (PD-1 / PD-L1 / CTLA4, etc.); 4. According to recistv1.1 standard, those subjects with at least one measurable tumor focus; 5. Subjects with ECoG PS of 0 or 1; 6. The patients or their families are willing to cooperate with the complete drug treatment tracking requirements.

Exclusion criteria

Exclusion criteria: 1. Subjects with metastatic cancer found in brain and other nervous systems; 2. Patients with acute or chronic hepatitis B or hepatitis C infection; 3. Subjects with active, known or suspected autoimmune diseases (type I diabetes, hypothyroidism with hormone replacement therapy only, except for skin diseases without systemic treatment); 4. Patients with previous malignant tumors (except bladder cancer, gastric cancer, colon cancer, endometrial cancer, breast cancer and other cancers in situ), unless they have been completely cured at least 2 years before participating in the study, and no additional treatment is required during the study; 5. Subjects who have received any chemotherapy, biological products for cancer treatment or experimental therapy within 28 days before the first administration; 6. Patients who refuse or are unable to complete the informed consent related communication of the study, or patients who withdraw from the study for some reason during the study; 7. For other exclusions, please consult the researchers.

Design outcomes

Primary

MeasureTime frame
5hmC;5mC;

Countries

China

Contacts

Public ContactWang Jie

National Cancer Center, Chinese Academy of Medical Sciences and Peking Union Medical College

wangjie@cicams.ac.cn+86 13810095769

Outcome results

None listed

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