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Clinical study of Carrilizumab combined with concurrent radiotherapy and chemotherapy in the treatment of locally advanced head and neck squamous cell carcinoma: prospective, randomized, controlled study

Clinical study of Carrilizumab combined with concurrent radiotherapy and chemotherapy in the treatment of locally advanced head and neck squamous cell carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041824
Enrollment
Unknown
Registered
2021-01-06
Start date
2020-12-30
Completion date
Unknown
Last updated
2021-03-30

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

experimental group:Carrilizumab+ Platinum chemotherapy + radiotherapy
control group:Platinum chemotherapy + radiotherapy

Sponsors

West District of the First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-75 years, male or female; 2. Patients with stage III and IV head and neck squamous cell carcinoma confirmed by pathology or histology; 3. Patients with at least one measurable lesion (spiral CT scan >= 10 mm, meeting RECIST 1.1 standard); 4. Patients who have not received radical radiotherapy (except neoadjuvant therapy) or concurrent chemoradiotherapy, immunotherapy or targeted therapy; 5. Patients with indications for treatment; 6. ECoG score: 0-1; 7. Patients whose expected survival time is more than or equal to 3 months; 8. Patients with normal function of main organs meet the following criteria: (1) The standard of blood routine examination should be met (no blood transfusion or blood products within 14 days) HB >= 90 g/L ANC >= 1.5 * 10^9/L PLT >= 80 * 10^9/L (2) Biochemical tests should meet the following standards: TBIL 45 ml / min (Cockcroft Gault formula); 9. The patients who volunteered to join the study signed the informed consent, with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with severe uncontrollable infection; 2. Pregnant or lactating women; 3. Patients with known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.); 4. Other conditions considered by the researcher not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
ORR;DCR;OS;PFS;AE;

Countries

China

Contacts

Public ContactJin Gao

West District of the First Affiliated Hospital of University of Science and Technology of China

ahgj1234567@163.com+86 15395005376

Outcome results

None listed

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