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

Phase 2

Recruiting

• Conditions: Hypopharyngeal Cancer; Laryngeal Cancer
• Interventions: Drug: Toripalimab

• Registration Number: NCT05420597
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Historically, induction chemotherapy has been shown to increase laryngeal-preservation rate, improve disease-free survival and reduce the risk of distant metastasis. However, the prognosis of locally advanced laryngeal/ hypopharyngeal carcinoma remains poor. Recently, phase I-II clinical studies demonstrated excellent pathological response of induction PD-1 inhibitor with/without chemotherapy for locally advanced head and neck cancer. 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.

Study Timeline

• Study Start: 2021-04-07
• Status Verified: 2022-06
• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-12
• Last Update Submitted: 2022-06-12
• Study First Posted: 2022-06-15
• Last Update Posted: 2022-06-15
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Induction chemotherapy and Toripalimab	Toripalimab	Induction chemotherapy TP regimen combined with Toripalimab, followed by cisplatin-based concurrent chemoradiation.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2 year	From the rate of enrollment to first progression

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 year	From the rate of enrollment to death
Overall response rate of induction chemotherapy	up to 3 month	Overall response rate of induction chemotherapy, evaluated by MR/CT imaging per RECIST 1.1
Locoregional recurrence-free survival	2 year	From the rate of enrollment to first locoregional relapse
Distant metastasis-free survival	2 year	From the rate of enrollment to first distant metastasis
Laryngeal Preservation Rate	2 year	The incidence of those with partial/whole preservation of anatomic larynx, without evidence of local recurrence
Adverse Effect	up to 2 year	Adverse Effect, evaluated by CTCAE 4.0.03

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China