Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06039631

Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal/Hypopharyngeal Cancer

Led by Fudan University · Updated on 2023-09-15

82

Participants Needed

1

Research Sites

314 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

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.

CONDITIONS

Official Title

Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal/Hypopharyngeal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and willing to follow the study plan
  • Age 18 to 75 years
  • Histologically confirmed laryngeal or hypopharyngeal squamous cell carcinoma
  • Locally advanced cancer eligible for surgical removal (stages T2N+M0, T3-T4aN0-3M0)
  • At least one measurable tumor lesion before treatment per RECIST 1.1 criteria
  • Achieved partial response in the primary lesion after neoadjuvant immunotherapy plus chemotherapy
  • Expected survival longer than 3 months
  • ECOG performance status score of 0 or 1
  • Good organ function with specific blood counts, liver and kidney function, and coagulation within required limits
  • Allowed if inactive or controlled hepatitis B or C infection with low viral levels
  • Female participants of childbearing potential must have a negative pregnancy test and use contraception during and after treatment
  • Non-sterile male participants must use contraception during and after treatment
Not Eligible

You will not qualify if you...

  • Allergic reactions to toripalimab, paclitaxel, or cisplatin
  • Pre-existing tracheostomy due to laryngeal dysfunction
  • Other active or recent cancers except certain cured types
  • Uncontrolled heart conditions including heart failure, unstable angina, recent heart attack, or serious arrhythmias
  • Recent investigational drug use or participation in other clinical trials (except observational)
  • Recent systemic corticosteroid or immunosuppressive treatment (with some exceptions)
  • Recent anti-tumor or live vaccines or major surgery
  • Unresolved significant toxicity from prior cancer treatments
  • Severe infections or active pulmonary inflammation within 4 weeks before treatment
  • Active or history of autoimmune diseases (with some allowed stable conditions)
  • Immune deficiencies including HIV or history of organ/bone marrow transplant
  • Interstitial lung disease or non-infectious pneumonitis
  • Active or untreated tuberculosis
  • Active hepatitis B or C infections with high viral load
  • History of substance, alcohol abuse, or drug addiction
  • Pregnant or breastfeeding women
  • Other serious diseases or conditions that may affect study participation or safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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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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