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Establishment of a new method for blood concentration of camrelizumaband association of PD-1 gene polymorphism with drug efficacy and safetyin patients with head and neck squamous cell carcinoma

Establishment of a new method for blood concentration of camrelizumaband association of PD-1 gene polymorphism with drug efficacy and safetyin patients with head and neck squamous cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123139
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-05-05
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Camrelizumab trial group (exposed group):None

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Hospitalized patients histologically confirmed as having Head and Neck Squamous Cell Carcinoma (HNSCC); 2. Aged >=18 years and =3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Received at least 2 cycles of Camrelizumab treatment, with or without other anti-tumor drugs; 6. All patients underwent blood cell analysis, blood biochemistry, lipid profile, coagulation function, thyroid function, tumor marker tests, and imaging examinations prior to Camrelizumab infusion, to evaluate anti-tumor efficacy and monitor adverse drug reactions and toxicities; 7. Patients had complete medical records.

Exclusion criteria

Exclusion criteria: 1.Known allergy or intolerance to the study drug; 2.Communication disorders or mental illness; 3.Pregnant or breastfeeding women; 4.Concurrent presence of other types of tumors; 5.Severe primary diseases involving the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems; 6.History of tuberculosis or active pulmonary tuberculosis; 7.Severe autoimmune diseases; 8.Prior organ or hematopoietic stem cell transplantation; 9.Vaccination with live vaccines during the treatment period;

Design outcomes

Primary

MeasureTime frame
Steady-state plasma concentration of Camrelizumab;Disease Control Rate (DCR);PD-1 gene polymorphism;Objective Response Rate (ORR);Progression-Free Survival (PFS);

Secondary

MeasureTime frame
Causality assessment of irAEs;Occurrence and grading of immune-related adverse events (irAEs);

Countries

China

Contacts

Public ContactRong Wang

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

wangrong198521@126.com+86 21 5669 1101

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026