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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

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.