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

June 12, 2022 updated by: Xiayun He, MD, Fudan University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yu Wang, M.D.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction chemotherapy and Toripalimab
Induction chemotherapy TP regimen combined with Toripalimab, followed by cisplatin-based concurrent chemoradiation.
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).

Other Names:
  • JS001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 2 year
From the rate of enrollment to first progression
2 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xiayun He, M.D., Fudan University
  • Principal Investigator: Yu Wang, M.D., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

June 12, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 12, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INSIGHT-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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