Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal/Hypopharyngeal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
In the global landscape of cancer, head and neck malignancies are highly prevalent, with 878,000 new cases and 444,000 deaths recorded in 2020. Notably, laryngeal and hypopharyngeal cancers contribute to around 30% of these instances. More than 50% of patients are diagnosed with locally advanced disease, necessitating intensive treatments that significantly impact their quality of life. Despite these efforts, the prognosis for laryngeal and hypopharyngeal cancers remains grim, with a 5-year survival rate of 30% to 50%.
Past approaches focused on preserving laryngeal function and patient well-being, including minimally invasive surgery, advanced radiotherapy, and induction chemotherapy. Our prior research highlighted the effectiveness of combining toripalimab-based induction therapy and chemotherapy, followed by concurrent chemoradiotherapy or surgery. Positive short-term outcomes and manageable side effects were observed, with encouraging larynx preservation rates after one year.
Against this backdrop, the current study aims to explore neoadjuvant immunotherapy combined with chemotherapy for patients with locally advanced laryngeal and hypopharyngeal cancer. It seeks to compare the therapeutic efficacy and quality of life impacts of concurrent radiochemotherapy and organ-preserving surgery. The ultimate goal is to identify optimal strategies for future interventions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signing of the informed consent form and willingness to comply with the study protocol.
Age ≥18 and ≤75 years.
Histologically confirmed laryngeal or hypopharyngeal squamous cell carcinoma.
Locally advanced laryngeal/hypopharyngeal cancer patients eligible for surgical resection (AJCC 8th edition stage: T2N+M0, T3-T4aN0-3M0).
Disqualifiers
History of allergic reactions to any components of toripalimab, paclitaxel, or cisplatin.
Pre-existing tracheostomy due to laryngeal dysfunction before treatment.
History of or concurrent presence of other malignancies (except for those cured and with no cancer-related survival exceeding 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer). Patients with concurrent hypopharyngeal and esophageal cancers, where the lesions are not anatomically adjacent, will be diagnosed as having dual primary tumors and will not be eligible for inclusion.
NYHA Class II or higher heart failure.
Trial design
Design model
Parallel
Treatments tested in this trial
Surgery
Procedure/SurgeryIn the surgical group, patients will undergo curative surgery for laryngeal/hypopharyngeal cancer along with cervical lymph node dissection. Organ preservation surgery is recommended.
Radiation
RadiationIn the surgical group, depending on postoperative pathology results, adjuvant radiotherapy or concurrent radiochemotherapy may be administered as deemed necessary. If postoperative pathology indicates extracapsular invasion of lymph nodes or positive surgical margins, concurrent radiochemotherapy based on cisplatin is recommended. In the concurrent radiochemotherapy group, patients will undergo target delineation based on the scope before induction chemotherapy. Radiotherapy will be administered at a total dose of 70 Gy over 35 fractions, and concurrent chemotherapy will involve weekly administration of cisplatin at a dosage of 30 mg/m².
Toripalimab
DrugIn the both groups, starting three weeks after the completion of radiotherapy, patients will receive adjuvant immunotherapy using a specific protocol of toripalimab at a dose of 240 mg every 3 weeks for a total of 8 cycles.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Organ preservation surgeryExperimental treatment 3 interventions
Group B: Concurrent chemoradiationOther 2 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival rate
Progression-free survival is defined as the time interval from the commencement of randomization until the first documented occurrence of objective tumor progression or death due to any cause, whichever comes first.
Time frame
At two year post-randomizationSecondary outcomes
1
Larynx Preservation rate
Larynx-preservation is considered to have failed on the date of total laryngectomy, or evidence of local recurrence on primary site.
Time frame
At two year post-randomization2
Overall Survival rate
Overall survival is measured as the time from the initiation of randomization to the occurrence of death due to any cause.
Time frame
At two year post-randomization3
Quality of life
Evaluated by MD Anderson Dysphagia Inventory, Voice Handicap Index 10
Time frame
From enrollment to two year post-randomization4
Adverse events
Adverse events evaluated by CTCAE 5.0 criteria
Time frame
From enrollment to two year post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fudan University
Lead sponsor
Fudan University Eye Ear Nose and Throat Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
Ruijin Hospital
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov