Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
NCT ID: NCT05069857
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
46 participants
INTERVENTIONAL
2021-09-01
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Neoadjuvant arm
The patients received three cycles of neoadjuvant therapy, with 14 days each. Dosage and administration: 200mg Carrelizumab intravenously on the first day of each cycle; Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle. Then the patients received the standard treatment of surgery and postoperative adjuvant therapy of radiotherapy or chemoradiotherapy.
Camrelizumab (anti-PD-1 inhibitor)
The patients will receive three cycles of Camrelizumab, with 14 days each. 200mg of Carrelizumab will be used intravenously on the first day of each cycle.
Apatinib (anti-VEGFR inhibitor)
The patients will receive Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle.
Control arm
The patients received the standard treatment of surgery and postoperative adjuvant therapy of radiotherapy or chemoradiotherapy.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Camrelizumab (anti-PD-1 inhibitor)
The patients will receive three cycles of Camrelizumab, with 14 days each. 200mg of Carrelizumab will be used intravenously on the first day of each cycle.
Apatinib (anti-VEGFR inhibitor)
The patients will receive Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Gender: Male and female
3. ECOG Score: 0-2
4. Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)
5. Clinical stage III/IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2 /M0, AJCC 8th)
6. The combined positive score (CPS score) of PD-L1 expression \> 10
7. Has signed informed consent
Exclusion Criteria
2. Obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, ≥ grade 2 heart disease diagnosed according to the NYHA classification criteria within 3 months prior to enrollment)
3. Active severe clinical infection (\> NCI-CTCAE Version 5.0 level 2 infection)
4. Uncontrollable hypertension (systolic blood pressure \> after antihypertensive medication; 150mmHg and/or diastolic blood pressure \> 90mmHg) or clinically significant (such as activity) cardiovascular disease, such as cerebrovascular accident (≤ 6 months before screening), myocardial infarction (≤ 6 months before screening), unstable angina, congestive heart failure rated class II or above by NYHA, or severe arrhythmias that cannot be controlled or have a potential impact on trial treatment
5. Blood routine examination: WBC \< 3,000/mm3, hemoglobin \< 8g/L, platelet \< 80,000/mm3
6. Liver function: ALAT/ASAT \> 2.5 times the normal upper limit, bilirubin \> 1.5 times the normal upper limit
7. Renal function: serum creatinine \> 1.5 times the normal upper limit
8. Has a history of maxillofacial and neck radiotherapy
9. Pregnant or lactating women
10. Participation in other clinical studies within 30 days prior to enrollment
11. Other conditions that the investigator considers inappropriate for participation
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lai-ping Zhong
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lai-ping Zhong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Icemelting-2
Identifier Type: -
Identifier Source: org_study_id