Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer
ConditionHead & Neck Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTang-Du Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Nimotuzumab
Drugtreatment Regimen:Nimotuzumab was administered by intravenous infusion at a dose of 400 mg,d1, Q3W,for 2-4 cycles Other Name:
Toripalimab
Drugtreatment Regimen:Toripalimab was administered by intravenous infusion at a dose of 240 mg,d1,Q3W,for 2-4 cycles
Nab-paclitaxel
Drugtreatment Regimen:Nab-paclitaxel was administered by intravenous infusion at a dose of 260mg/m² ,d1, Q3W,for 2-4 cycles
carboplatin
Drugtreatment Regimen: Carboplatin dosage was calculated using the Calvert formula (dose = target AUC × \[GFR + 25\]), d1,IV,Q3W,for 2-4 cycles
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Nimotuzumab Combined with Toripalimab and ChemotherapyExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Pathological complete response rate (pCR)
no residual tumor cells in the primary lesion and lymph nodes after surgery (pathological assessment).
Time frame
Within 1-2 week after radical surgery (same time point as MPR assessment)Secondary outcomes
1
Surgical resection margin (first margin and second margin)
First margin: tumor margin before neoadjuvant therapy; Second margin: tumor margin after neoadjuvant therapy (defined as Clear margin per the 2025 NCCN Guidelines: the distance from invasive tumor to the resection margin ≥ 5 mm).
Time frame
Within 1-2 week after radical surgery (performed 2-3 weeks after the completion of 2 cycles of neoadjuvant treatment)2
Major pathological response rate (MPR)
residual tumor in the primary lesion \< 10% (pathological assessment).
Time frame
Within 1-2 week after radical surgery (performed 2-3 weeks after the completion of 2 cycles of neoadjuvant treatment)3
Radiological response rate
evaluated by contrast-enhanced CT/MRI before and after treatment (per RECIST 1.1 criteria: complete response \[CR\]/partial response \[PR\]/stable disease \[SD\]/progressive disease \[PD\]).
Time frame
After the completion of 2 cycles of neoadjuvant treatment (each cycle is 21 days)4
Functional preservation rate
Functional preservation rate was defined as the proportion of patients with normal phonation and swallowing function: before surgery, and 1 month, 6 months, and 1 year after surgery or radiotherapy (evaluated via video laryngoscopy + scale assessment + voice analysis)
Time frame
functional assessment: before surgery,and 1 month, 6 months, and 1 year after surgery or Concurrent chemoradiotherapySponsors and contacts
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Source ClinicalTrials.gov