An exploratory study of Carrilizumab combined with apatinib in locally advanced/metastatic head and neck squamous cell carcinoma with failed radiotherapy and chemotherapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052047

Enrollment

Unknown

Registered

2021-10-15

Start date

2021-10-15

Completion date

Unknown

Last updated

2022-06-27

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

Therapy group:Camrelizumab in combination with apatinib mesylate

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, male or female; 2. Patients with head and neck squamous cell carcinoma diagnosed by pathology or histology; 3. At least one measurable lesion (spiral CT scan >= 10 mm, meeting RECIST 1.1 standard); 4. Previous radiotherapy failure or recurrence and metastasis of advanced head and neck squamous cell carcinoma; 5. ECOG score: 0-2; 6. Estimated survival time >= 3 months; 7. The function of the main organs is normal: (1) The standard of blood routine examination should be met (no blood transfusion and blood products within 14 days): 1) HB >= 90 g/L; 2) ANC >= 1.5 x 10^9/L; 3) PLT >= 80 x 10^9/L; (2) Biochemical tests shall meet the following standards: 1) TBIL 45 ml/min (Cockcroft-Gault formula); 8. The subjects voluntarily joined the study and signed an informed consent form with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who have been confirmed to be allergic to experimental drugs and their excipients; 2. Patients with severe uncontrollable infection; 3. Pregnant or lactating women; 4. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophilia, coagulation dysfunction, thrombocytopenia, etc.); 5. There are uncontrolled clinical symptoms or diseases of the heart, such as (1) heart failure above NYHA 2 grade; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; 6. Suffers from hypertension and cannot be well controlled by antihypertensive drugs (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90 mmHg); 7. The researchers believe that it is not in line with the other conditions of the group.

Design outcomes

Primary

Measure	Time frame
ORR(objective response rate);	—

Secondary

Measure	Time frame
PFS(progress-free survival);OS(overall survival);DCR(disease control rate);	—

Countries

China

Contacts

Public ContactZhu Yiping

The First Affiliated Hospital of Wannan Medical College

zhuyiping@wnmc.edu.cn+86 13965197031

Outcome results

None listed

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