Tislelizumab and Induction Chemotherapy for Larynx Preservation in Resectable Advanced Laryngeal/Hypopharyngeal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHenan Cancer Hospital
About this trial
This study is a prospective, single-arm, single-center, phase II study. The goal of this clinical trial is to explore the therapeutic value of the treatment model of "tislelizumab combined with chemotherapy followed by radiotherapy/adaptive surgery" on larynx Preservation of locally advanced hypopharyngeal cancer and laryngeal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed, resectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma (T2-4a, N0-resectable N3, M0);
Age between 18-70 years;
Had at least one measurable lesion according to RECIST 1.1 criteria;
Anticipated overall survival more than 3 months;
Disqualifiers
Hypersensitivity to tislelizumab, Paclitaxel or Cisplatin.
Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy.
Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
There is distant metastasis.
Trial design
Design model
Single group
Treatments tested in this trial
chemotherapy TP regimen combined with Tislelizumab
DrugInduction chemotherapy TP regimen combined with Tislelizumab for 3 cycles: Cisplatin 37.5mg/m2 d1-2 q3w, Docetaxel 37.5mg/m2 d1and d3 q3w,Tislelizumab 200mg d3 q3w. •Response rate of primary tumor or lymph nodes is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If the primary lesion reaches CR/PR and the lymph nodes reach CR, chemoradiotherapy based on cisplatin is conducted. If the primary lesion reaches CR/PR and lymph node PR/PD, cervical lymph node dissection will be performed, followed by radiotherapy/concurrent chemoradiotherapy. If the primary lesion is SD/PD, regardless of the condition of the lymph nodes, primary lesion resection and lymph node dissection should be performed, followed by adjuvant radiation/chemoradiation. Other Names: Docetaxel Cisplatin Paclitaxel
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: Tislelizumab and Induction Chemotherapy Followed by Radiotherapy or Adaptive SurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Laryngeal preservation rate at 3 months after radiotherapy
defined as the absence of any residual disease that would justify salvage total laryngectomy
Time frame
3-month post-radiotherapySecondary outcomes
1
Objective response rate after induction chemoimmunotherapy
2 weeks after the 3th cycle of induction therapy
Time frame
2 weeks after the end of cycle 3 of induction therapy2
Overall survival rate at 1 year
Overall survival rate at 1 year
Time frame
One year post-radiotherapy3
Laryngeal preservation rate at 1 year after radiotherapy
defined as the absence of any residual disease that would justify salvage total laryngectomy
Time frame
1 year post-radiotherapy4
Progression-free survival rate at 1 year
Progression-free survival rate at 1 year
Time frame
One year post-radiotherapySponsors and contacts
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Source ClinicalTrials.gov
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