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

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) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.

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

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: 61
Treatments
Experimental: Induction chemotherapy and Toripalimab
Induction chemotherapy TP regimen combined with Toripalimab, followed by cisplatin-based concurrent chemoradiation.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov