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

Laryngeal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420597
• Other study ID #: INSIGHT-2
• Status: Recruiting
• Phase: Phase 2
• Start date: April 7, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2022
• Source: Fudan University
• Contact: Xiayun He, M.D.
• Phone: (86)021-64175590
• Email: hexiayun1962[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypopharyngeal Cancer
• Hypopharyngeal Neoplasms
• Laryngeal Cancer
• Laryngeal Neoplasms

Intervention

Drug:
• Toripalimab
Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2,Cisplatin 25mg/m2 d2-4 q3w. Then a total dose of 70Gy in 35 fractions was administered, with concurrently weekly cisplatin (30mg/m2 qw). At 3-6 weeks post-radiotherapy, maintenance Toripalimab was administered for 8 cycles (240mg d1 q3w, in total 8 cycles).

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

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