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

Launched by FUDAN UNIVERSITY · Jun 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced laryngeal or hypopharyngeal cancer that cannot be surgically removed. The trial combines two types of treatment: induction chemotherapy and a medication called Toripalimab, which helps the body’s immune system fight cancer. After these treatments, patients will receive radiotherapy. The main goal is to see if this combination helps patients live longer without their cancer getting worse.

To join the trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of locally advanced laryngeal or hypopharyngeal cancer. They should have at least one area of cancer that can be measured and expected to live for more than three months. Participants will need to sign a consent form and meet certain health criteria. Those with specific health issues or who have had certain treatments in the past may not be eligible. If someone is selected for the trial, they will receive close monitoring and support throughout the treatment process.

Gender

ALL

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.