Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer (NCT07353723) | Clinical Trial Compass
RecruitingPhase 2
Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer
China10 participantsStarted 2025-11-15
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
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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 1.1.
✓. 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;
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).
What they're measuring
1
Pathological complete response rate (pCR)
Timeframe: Within 1-2 week after radical surgery (same time point as MPR assessment)