Induction Chemotherapy and Toripalimab for Larynx Preservation in Resectable Laryngeal/Hypopharyngeal Carcinoma
- Conditions
- Laryngeal CancerHypopharynx CancerLaryngeal Neoplasms
- Interventions
- Drug: chemotherapy TP regimen combined with Toripalimab
- Registration Number
- NCT04995120
- Lead Sponsor
- Fudan University
- Brief Summary
The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.
- Detailed Description
Historically, induction chemotherapy could provide a chance of larynx preservation for approximate 60-70% of patients with locally advanced laryngeal/hypopharyngeal carcinoma. Recently, phase I-II clinical studies demonstrated excellent pathological response of induction PD-1 inhibitor with/without chemotherapy for locally advanced head and neck cancer. The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
- Pathologically confirmed, resectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma (T2-4a, N0-resectable N3, M0);
- Age between 18-75 years;
- Signed inform consent;
- Had at least one measurable lesion according to RECIST 1.1 criteria
- Anticipated overall survival more than 3 months;
- Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
- Normal organ function;
- HBV DNA<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
- Male and no pregnant female, able to adapt birth control methods during treatment.
- Hypersensitivity to Toripalimab, Paclitaxel, Nab-Paclitaxel and Cisplatin;
- Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
- Severe, uncontrolled heart disease;
- Receive vaccine or live vaccine within 28 days prior to signing the informed consent;
- Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent;
- Surgery or trauma within 28 days prior to signing the informed consent;
- Received other immune checkpoint inhibitors previously;
- Severe, uncontrolled infections within 28 days of prior to signing the informed consent;
- Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit;
- History of interstitial lung disease;
- HIV positive;
- Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
- Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors;
- Women of child-bearing potential who are pregnant or breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Induction chemotherapy and Toripalimab chemotherapy TP regimen combined with Toripalimab Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2 or Nab-Paclitaxel 260mg/m2 d2，Cisplatin 25mg/m2 d2-4 q3w. Response rate of primary tumor is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If ORR of primary tumor is CR/PR, then chemoradiation is conducted, followed by maintenance therapy of Toripalimab for 8 cycles (6 months). Otherwise, surgery is conducted (laryngeal preservation surgery is preferred), followed by adjuvant radiation/chemoradiation and then maintenance therapy of Toripalimab for 8 cycles.
- Primary Outcome Measures
Name Time Method Laryngeal Preservation rate at 3-month post-radiotherapy 3-month post-radiotherapy defined as the absence of any residual disease that would justify salvage total laryngectomy
- Secondary Outcome Measures
Name Time Method Major pathologic response rate of the patients receiving surgical resection Within 3 weeks after surgery Major pathologic response rate, defined as no more than 10% of residual viable tumor, evaluated by experienced pathologists.
Progression-free survival rate at 1 year One year post-radiotherapy Progression-free survival rate at 1 year
Pathological complete response rate of the patients receiving surgical resection Within 3 weeks after surgery Pathological complete response rate of the patients receiving surgical resection, evaluated by experienced pathologists
Laryngeal Preservation rate at 1 year One year post-radiotherapy Laryngeal Preservation rate at 1 year
Laryngeal Preservation rate at 2 year Two year post-radiotherapy Laryngeal Preservation rate at 2 year
Adverse Effect One year post-radiotherapy Adverse Effect, evaluated by CTCAE 4.0.03
Overall response rate of induction therapy 2 weeks after the 3th cycle of induction therapy Overall response rate of induction therapy evaluated by head and neck MR/CT, laryngoscopy using Recist 1.1 Criteria
Overall response rate of treatment 3 months post-radiotherapy Overall response rate of treatment evaluated by head and neck MR/CT, laryngoscopy using Recist 1.1 Criteria
Overall survival rate at 1 year One year post-radiotherapy Overall survival rate at 1 year
Overall survival rate at 2 year Two year post-radiotherapy Overall survival rate at 2 year
Progression-free survival rate at 2 year Two year post-radiotherapy Progression-free survival rate at 2 year
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China