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The establishment of a personalized monitoring system for PD-1 monoclonal antibody using TDM technology and a multicenter randomized, open study to improve safety in patients with non-small cell lung cancer

The establishment of a personalized monitoring system for PD-1 monoclonal antibody using TDM technology and a multicenter randomized, open study to improve safety in patients with non-small cell lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036876
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-25
Completion date
Unknown
Last updated
2020-09-21

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

No intervention group:Routine pharmaceutical care was performed using the pharmaceutical care essentials recommended in the Guidelines on Whole-process Pharmaceutical Care for Immunocheckpoint inhibit
intervention group:Routine pharmaceutical care was carried out according to the recommended pharmaceutical care points of the Guidelines on Whole-process Pharmaceutical Care for Immunocheckpoint inhib

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Real world patients in relevant departments of each center, aged from 18 to 80 years old, male or female; (2) in accordance with para bead sheet resistance to isle of non-small cell lung cancer indications (epidermal growth factor receptor gene mutation invisible and anaplastic lymphoma kinase negative metastatic squamous non-small cell lung cancer, TPS of 1% or more negative epidermal growth factor receptor gene mutations and anaplastic lymphoma kinase negative locally advanced or metastatic non-small cell lung cancer and metastatic squamous non-small cell lung cancer), choose with palmer show bead resistance to treatment of patients with clinical; (3) Volunteered to participate in this clinical study, willing to cooperate with the requirements of this project for TDM monitoring, and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Allergic to the active ingredients or excipients contained in this product; (2) Patients with off-label indications using this product; (3) Metastatic patients with active tumors in the central nervous system; (4) Those whose ECOG PS score is above 3; (5) HIV, HBV, HCV and other infected persons; (6) Patients with active systemic autoimmune diseases; (7) Patients with interstitial lung disease; (8) Pneumonia patients who have previously required systemic corticosteroid therapy; (9) A history of severe allergy or immune-related adverse reaction to another monoclonal antibody; (10) those who have used systemic antibiotics in the past 1 month.

Design outcomes

Primary

MeasureTime frame
Number of immune-related adverse reactions;

Countries

China

Contacts

Public ContactWang Zhuo

Shanghai Changhai Hospital

wangzhuo088@163.com+86 13818390863

Outcome results

None listed

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