Actively Recruiting
Neoadjuvant Immunotherapy and Chemotherapy Followed by Concurrent Chemoradiation or Organ Preservation Surgery in Locally Advanced Laryngeal and Hypopharyngeal Cancer
Led by Fudan University · Updated on 2023-09-15
82
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
F
Fudan University Eye Ear Nose and Throat Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Head and neck cancer is one of the most common cancers worldwide, with laryngeal and hypopharyngeal cancers making up about 30% of cases. Many patients have advanced disease at diagnosis, which requires intense treatment that can affect their quality of life. Despite treatments including surgery, radiotherapy, and chemotherapy, the five-year survival rate remains low, between 30% and 50%. Recent advances in immunotherapy have shown promise when combined with chemotherapy in early studies. This trial compares two treatment approaches for patients with locally advanced laryngeal or hypopharyngeal cancer who have partially responded to initial immunotherapy and chemotherapy. One group receives surgery aimed at preserving the organ, possibly followed by radiotherapy or chemoradiotherapy based on pathology results. The other group receives concurrent radiochemotherapy with cisplatin. After completing radiotherapy, both groups receive adjuvant immunotherapy with toripalimab every three weeks for eight cycles. Participants will be followed for two years after randomization to assess progression-free survival, overall survival, larynx preservation, quality of life, and side effects. Assessments include regular clinical evaluations and monitoring of treatment effects and safety. The study aims to find the best strategy to improve outcomes and maintain quality of life for these patients.
CONDITIONS
Brief Title
Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal/Hypopharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willingness to follow the study protocol
- Age between 18 and 75 years
- Histologically confirmed laryngeal or hypopharyngeal squamous cell carcinoma
- Locally advanced cancer eligible for surgical resection (specific staging criteria)
- At least one measurable lesion before treatment per RECIST 1.1
- Partial response to neoadjuvant immunotherapy combined with chemotherapy
- Expected survival longer than 3 months
- ECOG performance status of 0 or 1
- Adequate organ function including specific blood counts and liver and kidney function
- Controlled hepatitis B or C infection within defined limits
- Negative pregnancy test for females of childbearing potential and use of contraception
- Willingness of non-sterilized males to use contraception
You will not qualify if you...
- Allergy to toripalimab, paclitaxel, or cisplatin
- Pre-existing tracheostomy due to laryngeal dysfunction
- History or presence of other malignancies except certain cured cancers
- Uncontrolled heart conditions including heart failure, unstable angina, recent myocardial infarction, or serious arrhythmias
- Recent use of investigational drugs or participation in other clinical trials (except observational)
- Use of systemic corticosteroids or immunosuppressants shortly before study
- Recent major surgery or severe trauma
- Unresolved severe toxicities from prior treatments
- Recent severe infections or active pulmonary inflammation
- Active or history of autoimmune diseases except stable hypothyroidism or controlled diabetes
- Immune deficiency conditions including HIV or organ transplantation
- History of interstitial lung disease or non-infectious pneumonitis
- Active or recent tuberculosis infection
- Active hepatitis B or C infection above specified levels
- Substance or alcohol abuse history
- Pregnant or breastfeeding women
- Other factors affecting compliance or safety as judged by investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration not specified
Participants receive neoadjuvant immunotherapy combined with chemotherapy before randomization to assess partial response.
Visit schedule as per treatment protocol
Duration - Duration not specified
Participants undergo curative organ preservation surgery with cervical lymph node dissection. Depending on pathology results, adjuvant radiotherapy or concurrent chemoradiotherapy may be administered as needed.
1 surgery visit plus additional visits depending on adjuvant therapy
Duration - Radiotherapy delivered in 35 fractions (approximately 7 weeks)
Participants receive concurrent chemoradiotherapy consisting of radiotherapy over 35 fractions with weekly cisplatin chemotherapy.
Weekly visits for radiotherapy and chemotherapy
Duration - Approximately 24 weeks (8 cycles at 3-week intervals)
Starting three weeks after the completion of radiotherapy or surgery-related therapies, participants receive adjuvant immunotherapy with toripalimab every 3 weeks for a total of 8 cycles.
Visits every 3 weeks for 8 cycles
Duration - Up to 2 years post-randomization
Participants are followed for assessment of progression-free survival, overall survival, larynx preservation, quality of life, and adverse events up to two years post-randomization.
Visits for assessments as scheduled up to 2 years
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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