This prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC.
This study plans to enroll 42 patients. After screening and qualifying the patients, they will be given the treatment of Cetuximab combined with Tislelizumab and the TP chemotherapy regimen. One cycle lasts for 3 weeks, and a total of 3 cycles will be carried out, followed by efficacy evaluation. 1. Patients evaluated as resectable will undergo surgical treatment. After the surgery, based on the postoperative pathology, it will be determined whether radiotherapy is needed. And then, 1 cycle of combined chemotherapy will be continued, followed by 1 - year maintenance treatment with Tislelizumab. 2. Patients evaluated as unsuitable for surgery will receive radical radiotherapy, followed by 1 - year maintenance treatment with Tislelizumab, until disease progression, intolerable adverse reactions occur, or the patient refuses to continue treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Conversion therapy stage: TP regimen: Albumin-bound paclitaxel+Platinum (Cisplatin or Carboplatin) Albumin-bound paclitaxel: 100 mg/m² by IV infusion, D1/D8, every 3 weeks (Q3W) Platinum: Cisplatin 75 mg/m² by IV infusion or Carboplatin AUC=5 mg/mL/min Q3W Cetuximab: The initial dose is 400 mg/m² by IV infusion for 1 week. Subsequently followed by 250 mg/m² IV infusion, D1/D8, Q3W. Tislelizumab: 200 mg by IV infusion, Q3W. 3 weeks/cycle, 3 cycles in total. Patients who have completed conversion therapy undergo efficacy evaluation. Radical therapy stage: Evaluated as operable: Undergo surgery, followed by one cycle of adjuvant chemotherapy according to the preoperative regimen. Evaluated as inoperable: Receive radical radiotherapy. Maintenance therapy stage: Tislelizumab for 1 year or until disease progression, intolerable toxicity, or patient refusal to continue treatment.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGObjective Response Rate (ORR)
Defined as the proportion of participants acquired Complete response (CR) or Partial response (PR) after conversion treatment. Based on RECIST 1.1.
Time frame: 6 months
R0 resection rate
Defined as the proportion of patients in whom no cancer cells are detected at the resection margin microscopically, with no residual cancer cells visible either macroscopically or microscopically, and the lesion is completely excised.
Time frame: 6 months
Major Pathological Response Rate (MPR)
Defined as the presence of 10% or less viable tumor cells in the resected specimen following preoperative therapy, as assessed by pathological examination.
Time frame: 6 months
Progression free survival (PFS)
Defined as the period from enrollment to disease progress or death.
Time frame: up to 5 years
Overall Survival (OS)
Defined as the period from enrollment to death from any cause
Time frame: up to 5 years
Adverse Event rate
The rate of adverse event after treatment
Time frame: up to 2 years
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