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The prospective, open, multi-center clinical study of Apatinib(Aitan) in non-first-line treating patient with recurrent/metastatic head and neck squamous cell carcinoma

The prospective, open, multi-center clinical study of Apatinib(Aitan) in non-first-line treating patient with recurrent/metastatic head and neck squamous cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-16008751
Enrollment
Unknown
Registered
2016-06-30
Start date
2016-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

recurrent / metastatic head and neck squamous cell carcinoma

Interventions

Sponsors

The fourth affiliated hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-70 years old; 2. head and neck tumor histologic diagnosis of squamous cell carcinoma; 3. pathology or clinical diagnosis of recurrence and distant metastasis, after at least one treatment of disease progress; 4. ECoG score=2; 5. is expected to life expectancy over 6 months; 6. without strict Center Department of pulmonary disease; 7. meet the following clinical laboratory standards: all indexes of liver and kidney function were in the upper limit of the normal value of 1. 5 times the range, the ANC is more than or equal to 1.5*10^9/L, PLT is equal to or larger than 80*10^9/L; 8. Signed informed consent forms.

Exclusion criteria

Exclusion criteria: 1) cognitive impairment. 2) combined with other cancer patients. 3) patients with contraindications: Aitan allergic to any ingredients should be disabled for active bleeding, ulcers, intestinal perforation, intestinal obstruction, after major surgery within 30 days, uncontrollable high blood pressure drugs, 3-4 heart failure (NYHA standards), severe liver and kidney dysfunction (level 4). 4) bleeding (except local bleeding) or coagulation abnormalities (APTT>1.5xULN or INR>1.5). 5) specialist antihypertensive treatment for poorly controlled high blood pressure (specialist treatment case systolic pressure >180mmHg and/or diastolic pressure >100mmHg). 6) Kidney Foundation disease with protein in the urine. 7),pregnancy, lactation, or fertile but not contraceptives for women. 8) drug or alcohol addicts. 9)Other researchers believe that patients with inappropriate

Design outcomes

Primary

MeasureTime frame
Progression-free survival;hematological toxicity;Non-hematological toxicity;

Secondary

MeasureTime frame
overall survival;Disease remission rate;quality of life;

Countries

China

Contacts

Public ContactLu Ying

The fourth affiliated hospital of Guangxi Medical University

1786734840@qq.com+86 13877282529

Outcome results

None listed

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