Status:
COMPLETED
Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Oral Cancer
VEGFR2 Inhibitor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
In patients with locally advanced oral squamous cell carcinoma (OSCC), due to the large tumor burden and neck lymph node metastasis, comprehensive treatment is recommended, including surgery, radiothe...
Eligibility Criteria
Inclusion
- Eastern cooperative oncology group performance status (ECOG PS) score: 0-2 points
- Pathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheeks, mouth floor, hard palate, posterior molar region)
- Clinical stage of III/IVA (AJCC 2018)
- Blood routine: white blood cells\> 3,000/mm3, hemoglobin\> 8g/L, platelets\> 80,000/mm3
- Liver function: Alanine Transaminase/Aspartate Transaminase \<2.5 times the upper limit of normal, bilirubin \<1.5 times the upper limit of normal
- Renal function: serum creatinine \<1.5 times the upper limit of normal
- Sign the informed consent
Exclusion
- There are still unresolved toxic reactions above CTCAE level 2 caused by previous anti-cancer treatment
- Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, heart disease of grade 2 or higher diagnosed according to the classification criteria of the New York Heart Association (NYHA) 3 months before enrollment\]
- Active severe clinical infection (\> CTCAE 5.0 version 2 infection)
- Difficult to control hypertension (systolic blood pressure\> 150 mmHg and / or diastolic blood pressure\> 90 mmHg) or cardiovascular disease with clinical significance (such as activity)-such as cerebrovascular accident (≤ 6 months before randomization), myocardial infarction (≤6 months before randomization), unstable angina, New York Cardiology Society (NYHA Appendix 5) congestive heart failure grade II or above, or severe arrhythmia that cannot be controlled with drugs or has potential impact on experimental treatment
- Women during pregnancy or lactation
- Participated in other clinical studies within 30 days before enrollment
- Other circumstances that the investigator thinks are not suitable for participating in the study
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04393506
Start Date
April 23 2020
End Date
November 10 2023
Last Update
November 22 2023
Active Locations (1)
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1
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China, 200011