NCT07353723
Recruiting
Phase 2
A Pilot Study to Assess Feasibility and Preliminary Efficacy of Neoadjuvant Nimotuzumab, Toripalimab, and Chemotherapy in Locally Advanced Tonsillar Cancer
Tang-Du Hospital0 sites10 target enrollmentStarted: November 15, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Tang-Du Hospital
- Enrollment
- 10
Overview
Brief Summary
This is a prospective,single-arm,Phase II clinical study to designed to evaluate the efficancy and safety of nimotuzumab Combined with Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer
Detailed Description
This study is a prospective,single-arm,Phase II clinical study to evaluate the efficancy and safety of nimotuzumab Combined with Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer,The study aims to explore whether nimotuzumab Combined with Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer, can improve the pathological complete response (pCR) and overall survival rate(OS) compared with the historical data. The study plans to enroll approximately 10 patients at Tangdu Hospital and expected to completed enrollment within 1 yeasrs,within an additional 5 years follow-up for the label-enrolled subject.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 to 80 years old (inclusive of 18 and 80 years), of either gender.
- •Histopathologically or cytologically confirmed, and diagnosed as resectable locally advanced tonsillar squamous cell carcinoma (TSCC) by MRI imaging.
- •At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.
- •Male subjects are eligible if they agree to comply with the following standards during treatment and for at least 180 days after the last cycle of chemotherapy:a) Prohibition of sperm donation;AND• Abstain from heterosexual intercourse as a usual and preferred lifestyle (long-term and persistent abstinence) and agree to maintain abstinence;OR• Agree to use contraceptive measures unless confirmed as azoospermic (vasectomy or secondary to medical reasons, see Appendix 5), with details as follows:→ Use a male condom during penile-vaginal intercourse with a reproductive-aged female partner who is not currently pregnant, and the partner uses an additional contraceptive method.Note: Males whose partners are pregnant or breastfeeding must agree to either maintain abstinence from penile-vaginal intercourse at all times or use a male condom for every penile-vaginal penetration.b) Male subjects must also agree to use a male condom during any activity that allows ejaculation with others of any gender.c) Contraceptive methods used by males must comply with regulations regarding contraception in clinical research participation.
- •Female subjects are eligible if they are not pregnant or breastfeeding, and meet at least one of the following conditions:(1) Not a woman of childbearing potential (WOCBP);OR(2) If a WOCBP, use a highly effective contraceptive method (annual failure rate \<1%) with low user dependence, or abstain from heterosexual intercourse as a preferred and regular lifestyle (long-term and persistent abstinence) during the intervention period and for at least 210 days after the last cycle of chemotherapy, and agree not to donate ova (eggs, oocytes) to others or freeze/store ova for personal reproductive purposes during this period. Investigators shall evaluate the likelihood of contraceptive method failure (i.e., non-compliance, recent initiation) relative to the first administration of study treatment.a) WOCBP must have a negative result on a highly sensitive urine or serum pregnancy test (urine or serum test selected per regulatory requirements) within 24 hours (urine) or 72 hours (serum) before the first administration of study treatment to be enrolled.Note: If the interval between the screening pregnancy test and the first administration of study intervention exceeds 24 hours (urine) or 72 hours (serum), a repeat pregnancy test (urine or serum) must be performed, and the result must be negative for the subject to start receiving study medication.b) If a urine test is inconclusive (e.g., unclear result), a serum pregnancy test is required. In such cases, subjects with a positive serum pregnancy test result must be excluded.c) Investigators are responsible for reviewing medical history, menstrual history, and recent sexual activity to reduce the risk of enrolling women with undetected early pregnancy.d) Contraceptive methods used by females must comply with regulations regarding contraception in clinical research participation;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 within 3 days before the first administration of study intervention.
- •Evidence of extranodal extension (ENE) in lymph nodes (confirmed by MRI, CT, or pathology).
- •Voluntarily sign the written informed consent form for the study.
- •Expected survival time ≥6 months.
- •Adequate organ function as indicated by screening laboratory test results.a) Hematological parameters:White blood cell (WBC) count ≥4 × 10⁹/L;Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;Platelet count ≥100 × 10⁹/L;Hemoglobin (Hb) ≥90 g/L;b) Renal function:Serum creatinine ≤1.5 × upper limit of normal (ULN), or creatinine clearance (CrCl) \>60 mL/min (calculated using the Cockcroft-Gault formula):Female: CrCl = \[(140 - age) × body weight (kg) × 0.85\] / (72 × Scr \[mg/dL\])Male: CrCl = \[(140 - age) × body weight (kg) × 1.00\] / (72 × Scr \[mg/dL\])c) Hepatic function:Serum total bilirubin ≤1.5 × ULN;Aspartate aminotransferase (AST) ≤2.5 × ULN;Alanine aminotransferase (ALT) ≤2.5 × ULN;d) Coagulation function:International Normalized Ratio (INR) ≤1.5;Prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5 × ULN.
Exclusion Criteria
- •Prior systemic therapy for advanced (metastatic) or unresectable (locally advanced) tonsillar cancer, except for permitted neoadjuvant/adjuvant therapy. Neoadjuvant/adjuvant therapy must have been completed at least 6 months before the diagnosis of advanced and/or unresectable disease. Subjects who received prior neoadjuvant/adjuvant therapy and had R2 pathology after tumor resection are excluded.
- •Active autoimmune disease requiring systemic therapy (i.e., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic therapy and are permitted.
- •Major surgery prior to the initiation of study intervention with inadequate recovery from surgery and/or surgical complications.
- •Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
- •Prior treatment with EGFR-targeted agents.
- •Anti-tumor therapy for advanced tonsillar cancer, including investigational drugs, within 4 weeks before enrollment.
- •Unresolved adverse events (AEs) from prior anti-cancer therapy (i.e., AEs \> Grade 1 or baseline). Subjects with neuropathy ≤ Grade 2 may be eligible based on investigator assessment.
- •Radiotherapy within 2 weeks before the start of investigational treatment. Subjects must have recovered from all radiotherapy-related toxicities, be free of corticosteroid use, and have no history of radiation pneumonitis. A 1-week washout period is permitted for palliative radiotherapy (≤2 weeks of radiotherapy) for non-central nervous system (CNS) disease (if deemed safe by the investigator). A 2-week washout period is required for longer radiotherapy courses (\>2 weeks).
- •Administration of live vaccines within 30 days before the first dose of study drug.Note: Live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines administered by injection are generally inactivated virus vaccines and are permitted; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not permitted.
- •Current or prior participation in a study of an investigational drug, or use of an investigational device within 4 weeks before the first dose of study drug.Note: Subjects who have entered the follow-up phase of an investigational study are eligible to participate in this study if at least 4 weeks have passed since the last dose of the prior investigational drug.
Investigators
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