Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
NCT ID: NCT05125055
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
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RECRUITING
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2021-10-01
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neoadjuvant TTP
The participants will receive two cycles of intravenous Albumin paclitaxel (260mg/ m\^2), Cisplatin (75mg/ m\^2) and Toripalimab (anti-PD-1 inhibitor, 240 mg) on d1 and d22.
Toripalimab (anti-programmed death-1 inhibitor)
The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle.
Albumin paclitaxel
The participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.
Cisplatin
The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m\^2 of Cisplatin will be used intravenously on the first day of each cycle.
Neoadjuvant TPF
The participants will receive two cycles of intravenous Docetaxel (75 mg/m\^2) on d1 and d22, Cisplatin (75 mg/m\^2) on d1 and d22, and 5-Fluorouracil (750 mg/m\^2/day) for 5 days (d1-5 and d22-26), the interval is 16±1 days.
Cisplatin
The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m\^2 of Cisplatin will be used intravenously on the first day of each cycle.
Docetaxel
The participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m\^2 of Docetaxel will be used intravenously on the first day of each cycle.
5-Fluorouracil
The participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.
Interventions
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Toripalimab (anti-programmed death-1 inhibitor)
The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle.
Albumin paclitaxel
The participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.
Cisplatin
The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m\^2 of Cisplatin will be used intravenously on the first day of each cycle.
Docetaxel
The participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m\^2 of Docetaxel will be used intravenously on the first day of each cycle.
5-Fluorouracil
The participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.
Eligibility Criteria
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Inclusion Criteria
2. Gender: male and female
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
4. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
5. Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
6. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
7. Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3
8. Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) \<2.5 times the upper limit of normal and bilirubin \<1.5 times the upper limit of normal
9. Renal function: Serum creatinine \<1.5 times the upper limit of normal
10. Coagulation function: INR, PT, APTT\<1.5 times the upper limit of normal
11. Signed the informed consent form
Exclusion Criteria
2. Known allergic reaction to any ingredients or excipients of the therapy
3. Known history of malignancy, unless been cured and no recurrence for 5 years
4. Known history of radiation to head and neck
5. Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
6. Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\]
7. Patients receiving immunology-based treatment for any reason
8. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
9. Pregnant or lactating women
10. Uncontrollable hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment
11. Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation
12. Participation in other clinical trials within 30 days before enrollment
13. Other situations that the investigator considers unsuitable with respect to participating in the trial
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Lai-ping Zhong
Professor
Locations
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Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Illuminate-2
Identifier Type: -
Identifier Source: org_study_id