Induction Chemotherapy and Toripalimab for Larynx Preservation in Resectable Laryngeal/Hypopharyngeal Carcinoma

Launched by FUDAN UNIVERSITY · Aug 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with certain types of laryngeal or hypopharyngeal cancers, specifically looking at whether combining induction chemotherapy with a medication called Toripalimab can help preserve the larynx (voice box) in patients whose cancer can still be surgically removed. The goal is to see if this combination can improve outcomes for patients with locally advanced cancer that has not spread to distant areas.

To be eligible for this trial, participants should be between 18 and 75 years old and have a confirmed diagnosis of resectable (able to be surgically removed) laryngeal or hypopharyngeal cancer. They should also be in good general health, with specific organ functions, and should not have certain serious medical conditions or recent surgeries. Participants will receive the treatment and will be monitored closely throughout the study to assess how well the treatment works and what side effects may occur. This trial is currently recruiting participants, so if you or someone you know meets the criteria, it may be a valuable opportunity to consider.

Gender

ALL

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.