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

Primary Purpose

Laryngeal Cancer, Hypopharyngeal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngeal Cancer focused on measuring Induction chemotherapy, Immunotherapy, Toripalimab, Radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction chemotherapy and Toripalimab

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival
From the rate of enrollment to first progression

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2022
Last Updated
June 12, 2022
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05420597
Brief Title
Induction Chemotherapy and Toripalimab Followed by Radiotherapy in Unresectable Laryngeal/Hypopharyngeal Carcinoma
Official Title
Induction Chemotherapy and Toripalimab Followed by Radiotherapy in Unresectable Laryngeal/Hypopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Cancer, Hypopharyngeal Cancer
Keywords
Induction chemotherapy, Immunotherapy, Toripalimab, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Induction chemotherapy with toripalimab, followed by cisplatin-based concurrent chemoradiation. At 3-6 weeks post-radiation, maintenance toripalimab was administered for 8 cycles.
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction chemotherapy and Toripalimab
Arm Type
Experimental
Arm Description
Induction chemotherapy TP regimen combined with Toripalimab, followed by cisplatin-based concurrent chemoradiation.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Other Intervention Name(s)
JS001
Intervention Description
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).
Primary Outcome Measure Information:
Title
Progression-free survival
Description
From the rate of enrollment to first progression
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Overall response rate of induction chemotherapy
Description
Overall response rate of induction chemotherapy, evaluated by MR/CT imaging per RECIST 1.1
Time Frame
up to 3 month
Title
Locoregional recurrence-free survival
Description
From the rate of enrollment to first locoregional relapse
Time Frame
2 year
Title
Distant metastasis-free survival
Description
From the rate of enrollment to first distant metastasis
Time Frame
2 year
Title
Overall survival
Description
From the rate of enrollment to death
Time Frame
2 year
Title
Laryngeal Preservation Rate
Description
The incidence of those with partial/whole preservation of anatomic larynx, without evidence of local recurrence
Time Frame
2 year
Title
Adverse Effect
Description
Adverse Effect, evaluated by CTCAE 4.0.03
Time Frame
up to 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiayun He, M.D.
Phone
(86)021-64175590
Ext
81400
Email
hexiayun1962@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, M.D.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiayun He, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yu Wang, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiayun He, MD
Phone
+86-18017312167
Email
hexiayun1962@126.com
First Name & Middle Initial & Last Name & Degree
Xiaomin Ou, MD
Phone
+86-18017317872
Email
0456218@fudan.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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