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A phase II trial of TP and Toripalimab neoadjuvant chemotherapy followed by Toripalimab concurrent radiotherapy for patients with local advanced laryngeal/hypopharyngeal carcinoma

A phase II trial of TP and Toripalimab neoadjuvant chemotherapy followed by Toripalimab concurrent radiotherapy for patients with local advanced laryngeal/hypopharyngeal carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033506
Enrollment
Unknown
Registered
2020-06-03
Start date
2020-06-02
Completion date
Unknown
Last updated
2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal carcinoma /hypopharyngeal carcinoma

Interventions

experimental group:TP and Toripalimab neoadjuvant chemotherapy followed by Toripalimab concurrent radiotherapy

Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with squamous cell carcinoma confirmed by histology and / or cytology; 2. The radiotherapy site must have at least one measurable focus patient who has passed MRI examination (RECIST 1.1 standard); 3. Clinical stage: t3-4n0-3m0 stage of laryngeal cancer, t2-3n0-3m0 stage of hypopharyngeal cancer (AJCC 8th Edition); 4. According to the criteria of the eastern tumor cooperation group (ECoG) (physical fitness score is 0 or 1); 5. The patient must be informed of the basic content of the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with previous history of severe hypersensitivity to any component of other monoclonal antibodies or PD-1 monoclonal antibodies; 2. Patients with other malignant tumors; 3. Patients with known or suspected autoimmune diseases and severe mental diseases; 4. Patients who have received systemic or local glucocorticoid treatment, need long-term use of immunosuppressive drugs or use of traditional anti-tumor herbs within 4 weeks before admission; 5. Patients who have been vaccinated with any anti infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment; 6. Pregnant and lactating women; 7. Patients younger than 18 or older than 65 years.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
Local replase-free survival rate;larynx preserve rate;Quality of life;overall survival;

Countries

China

Contacts

Public ContactAnkui Yang

Department of Head and Neck Surgery, Department of Head and Neck Surgery, Sun Yat-Sen University Cancer Center

yangak@sysucc.org.cn+86 13903052829

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026