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

Fudan University

Status and phase

Enrolling

Phase 2

Conditions

Laryngeal Cancer

Hypopharyngeal Cancer

Treatments

Drug: Toripalimab

Study type

Interventional

Funder types

Other

Identifiers

NCT05420597

INSIGHT-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.