Combining chemotherapy and immunotherapy followed by radiotherapy for advanced laryngeal and hypopharyngeal cancer

Induction Chemotherapy and Toripalimab Followed by Radiotherapy in Unresectable Laryngeal/Hypopharyngeal Carcinoma

This study is testing if combining a specific cancer drug with chemotherapy and then using radiation can help people with advanced throat cancer live longer without their cancer getting worse.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: Toripalimab, prednisone, chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05420597 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of combining induction chemotherapy with the PD-1 inhibitor Toripalimab, followed by radiotherapy, in improving progression-free survival for patients with unresectable laryngeal and hypopharyngeal carcinoma. The approach is based on previous findings that suggest induction chemotherapy can enhance laryngeal preservation and reduce metastasis risk. Participants will receive Toripalimab alongside chemotherapy before undergoing radiotherapy. The study focuses on patients with locally advanced cancer who are not candidates for surgical intervention.

Who should consider this trial

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

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

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced laryngeal and hypopharyngeal cancer.

How similar studies have performed: Previous studies have shown promising results with similar combinations of chemotherapy and PD-1 inhibitors in treating head and neck cancers.

Eligibility criteria

Inclusion Criteria:

* Pathologically confirmed, unresectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma due to extensively local invasion or medical comorbidities (T3-4b, N0-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 and bone marrow 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 or 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 University
• Study coordinator: Xiayun He, M.D.

Conditions: Laryngeal Cancer, Hypopharyngeal Cancer, Induction chemotherapy, Immunotherapy, Toripalimab, Radiotherapy