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Study on the use of DNA methylation marker for prediction and evaluation of response to immune checkpoint inhibitors

Study on the use of DNA methylation marker for prediction and evaluation of response to immune checkpoint inhibitors

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053369
Enrollment
Unknown
Registered
2021-11-20
Start date
2021-11-20
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Metastatic lung cancers, advanced digestive tract cancers, advanced head and neck cancer, and other advanced malignant tumors

Interventions

Sponsors

Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged >= 18 years. 2. Patients with advanced cancer who have been confirmed by histology or cytology and who have received immunotherapy (not limited to cancer types). 3. Subjects must have measurable lesions by CT or MRI according to RECIST 1.1 criteria. 4. Patients who have previously failed standard treatment and/or cannot tolerate standard treatment and are planning to receive immunotherapy. 5. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1. The expected survival time is less than 3 months. 2. Received anti-tumor vaccine or other anti-tumor drugs with immunostimulatory effect. 3. Received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti-CTLA-4 antibody treatment (including ipilimumab or any specific action on T cell costimulation or checkpoint pathway) other antibodies or drugs). 4. The patient is undergoing other trials against concomitant drug treatment, and the drug cannot be discontinued during the study. 5. The investigator believes that the patient's medical history or concurrent conditions may affect the patient's ability to comply with the trial. 6. Other conditions deemed inappropriate by the researcher.

Design outcomes

Primary

MeasureTime frame
DNA methylation;Objective Response Rate;

Secondary

MeasureTime frame
Sum of longest diameters of target lesions;Overall survival;

Countries

China

Contacts

Public ContactZhang Yanjie

Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

zhangyanjie@shsmu.edu.cn+86 139 1812 7612

Outcome results

None listed

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