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

Who is this study for? Patients with resectable laryngeal/hypopharyngeal carcinoma
What treatments are being studied? Chemotherapy TP regimen+Toripalimab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xiayun He, M.D.
hexiayun1962@126.com
(86)021-64175590
Backup
Yu Wang, M.D.
Time Frame
Start Date: 2021-04-07
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 42
Treatments
Experimental: Induction chemotherapy and Toripalimab
Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2 or Nab-Paclitaxel 260mg/m2 d2,Cisplatin 25mg/m2 d2-4 q3w.~Response rate of primary tumor is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If ORR of primary tumor is CR/PR, then chemoradiation is conducted, followed by maintenance therapy of Toripalimab for 8 cycles (6 months). Otherwise, surgery is conducted (laryngeal preservation surgery is preferred), followed by adjuvant radiation/chemoradiation and then maintenance therapy of Toripalimab for 8 cycles.
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov