Neoadjuvant Toripalimab + Chemotherapy ± Cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma (Neo-ICT)
NCT ID: NCT06647563
Last Updated: 2024-10-18
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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NOT_YET_RECRUITING
PHASE3
355 participants
INTERVENTIONAL
2024-11-01
2030-09-30
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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Toripalimab + Chemotherapy + Cetuximab + SOC (Immunotherapy+ chemotherapy+targeted therapy, ICT)
Participants will receive an intravenous (IV) infusion of Toripalimab 240mg on Day 1, Albumin-bound Paclitaxel 125mg/m\^2 on Days 1 and 8, Carboplatin with an area under the curve (AUC) of 5 on Day 1, and Cetuximab 400mg/m\^2 on Day 1, followed by Cetuximab 250mg/m\^2 on Day 1 of each subsequent week. The treatment is given in 21-day cycles for a total of two cycles. Afterward, participants will proceed to the standard of care (SOC), which includes surgical intervention and postoperative radiotherapy. Following surgical resection, high-risk participants will receive standard radiotherapy plus Cisplatin 100 mg/m\^2 via intravenous infusion on Day 1, every 3 weeks (Q3W) for three 21-day cycles. Low-risk participants will receive only standard radiotherapy. Subsequently, participants will receive Toripalimab 240mg every 21-day cycle for a total of 15 cycles.
Toripalimab
Specified dose on specified days
Cetuximab
Specified dose on specified days
Albumin-Bound Paclitaxel
Specified dose on specified days
Carboplatin
Specified dose on specified days
Cisplatin
Specified dose on specified days
Radiotherapy 60 Gray/day
Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 66 Gray/day
High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 70 Gray/day
Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.
Toripalimab + Chemotherapy + SOC (Immunotherapy+ chemotherapy, IC)
Participants will receive an intravenous (IV) infusion of Toripalimab 240mg on Day 1, Albumin-bound Paclitaxel 125mg/m\^2 on Days 1 and 8, Carboplatin with an area under the curve (AUC) of 5 on Day 1. The treatment is given in 21-day cycles for a total of two cycles. Afterward, participants will proceed to the standard of care (SOC), which includes surgical intervention and postoperative radiotherapy. Following surgical resection, high-risk participants will receive standard radiotherapy plus Cisplatin 100 mg/m\^2 via intravenous infusion on Day 1, every 3 weeks (Q3W) for three 21-day cycles. Low-risk participants will receive only standard radiotherapy. Subsequently, participants will receive Toripalimab 240mg every 21-day cycle for a total of 15 cycles.
Toripalimab
Specified dose on specified days
Albumin-Bound Paclitaxel
Specified dose on specified days
Carboplatin
Specified dose on specified days
Cisplatin
Specified dose on specified days
Radiotherapy 60 Gray/day
Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 66 Gray/day
High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 70 Gray/day
Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.
No Neoadjuvant + SOC (Control)
Participants will receive the standard of care (SOC) with no neoadjuvant prior to surgery. Following surgical resection, high-risk participants will receive standard radiotherapy plus Cisplatin 100 mg/m\^2 via intravenous infusion on Day 1, every 3 weeks (Q3W) for three 21-day cycles. Low-risk participants will receive only standard radiotherapy.
Cisplatin
Specified dose on specified days
Radiotherapy 60 Gray/day
Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 66 Gray/day
High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 70 Gray/day
Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.
Interventions
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Toripalimab
Specified dose on specified days
Cetuximab
Specified dose on specified days
Albumin-Bound Paclitaxel
Specified dose on specified days
Carboplatin
Specified dose on specified days
Cisplatin
Specified dose on specified days
Radiotherapy 60 Gray/day
Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 66 Gray/day
High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.
Radiotherapy 70 Gray/day
Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female, aged 18-75 years;
3. Clinical stage III-IVb (AJCC 8th edition TNM stage) and operable patients; if oropharyngeal squamous cell carcinoma (P16-), the stage is III-IVb; if oropharyngeal squamous cell carcinoma (P16+), the stage is III;
4. No prior antitumor therapy including radiotherapy, chemotherapy, immunotherapy or biological therapy for the current tumor;
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
6. Life expectancy ≥ 6 months;
7. No obvious contraindications to immunotherapy, radiochemotherapy, or surgical treatment;
8. Willing to accept surgical treatment;
9. The level of main organ function meets the following criteria:
1. Routine blood tests: WBC ≥ 4.0 × 10\^9/L, ANC ≥ 1.5 × 10\^9/L, PLT ≥ 100 × 10\^9/L, Hb ≥ 90 g/L (no blood transfusion or blood products within 14 days, no correction with G-CSF and other hematopoietic growth factors);
2. Biochemical assessments: serum albumin ≥ 3.0 g/dL (30 g/L), TBIL ≤ 1.5 × ULN, ALT, AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula);
3. Adequate coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; If the subject is receiving anticoagulant therapy, PT should be within the proposed therapeutic range of the anticoagulant;
10. Women of childbearing potential must have a negative pregnancy test result (serum or urine), conducted within seven days prior to enrollment and agree to use effective contraception during the study period and for six months post last dose of anti-PD-1 antibody administration. Male subjects with female partners who are capable of conception must also utilize effective contraception throughout this study duration and for six months after their final dose anti-PD-1 antibody;
11. Willingness to participate in this study by signing an informed consent form, while exhibiting strong compliance and readiness to cooperate with follow-up procedures.
Exclusion Criteria
2. Active autoimmune disease. Subjects in stable condition who do not require systemic immunosuppressive therapy are permitted; examples include type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions that do not necessitate systemic treatment (e.g., vitiligo, psoriasis, alopecia).
3. Patients with congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10\^4 copies/ml) or hepatitis C (positive antibody for HCV, and HCV-RNA above the lower limit of detection of the analytical procedure);
4. Known allergy to the study drug or any of its excipients; or serious allergic reaction to other monoclonal antibodies.
5. The occurrence of any of the following conditions within 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, NYHA class II or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure.
6. Vaccination with live vaccines within 4 weeks prior to the first dose of the study drug. Inactivated virus vaccine can be administered for seasonal flu, but not attenuated live influenza vaccines administered intranasally.
7. Known history of allogeneic organ transplant or allogeneic stem cell transplant.
8. The history of drug addiction and the abuse of psychoactive substances.
9. Pregnant or breastfeeding women.
10. Any other malignant neoplasm diagnosed within 5 years prior to study entry, except for carcinoma that is amenable to local treatment and has been cured, such as basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, carcinoma in situ of breast ductal, and papillary thyroid cancer.
11. Patients with other significant physical or mental health conditions, or laboratory test abnormalities that may elevate the risk of participation in the study or compromise the integrity of the study results, as determined by the investigators, are deemed unsuitable for participation in this study.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Responsible Party
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Yue He, MD
M.D.
Principal Investigators
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Yue He, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Central Contacts
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Other Identifiers
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JYKQ-2024-105
Identifier Type: -
Identifier Source: org_study_id
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