Combining chemotherapy and Toripalimab for preserving the larynx in cancer patients

Induction Chemotherapy and Toripalimab Followed by Surgery or Radiotherapy for Larynx Preservation in Resectable Laryngeal/Hypopharyngeal Carcinoma

This study is testing if combining a specific chemotherapy with the drug Toripalimab can help more patients with laryngeal or hypopharyngeal cancer keep their voice box.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: Toripalimab, prednisone, chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04995120 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of combining induction chemotherapy with the PD-1 inhibitor Toripalimab in improving larynx preservation rates for patients with resectable laryngeal and hypopharyngeal carcinoma. Historically, induction chemotherapy has allowed for larynx preservation in 60-70% of cases, and recent studies suggest that PD-1 inhibitors may enhance this outcome. Participants will receive a specific chemotherapy regimen alongside Toripalimab, and their responses will be closely monitored. The study focuses on patients with locally advanced squamous cell carcinoma of the larynx or hypopharynx who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed, resectable locally advanced laryngeal or hypopharyngeal squamous cell carcinoma.

Not a fit: Patients with severe uncontrolled heart disease or those who have hypersensitivity to the study drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase the rate of larynx preservation in patients with advanced laryngeal and hypopharyngeal cancers.

How similar studies have performed: Previous studies have shown promising results with PD-1 inhibitors in similar patient populations, indicating potential for success in this novel combination approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Xiayun He, M.D. — Fudan Universtiy Shanghai Cancer Center
• Study coordinator: Xiayun He, M.D.

Conditions Laryngeal Cancer; Hypopharynx Cancer; Laryngeal Neoplasms; Induction chemotherapy; Checkpoint inhibitor; PD-1 inhibitor; Toripalimab; Larynx preservation