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Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer

Primary Purpose

Locoregionally Advanced Laryngo-hypopharyngeal Squamous Cell Cancer

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

5-Fluorouracil, Cisplatin, Toripalimab

About this trial

This is an interventional treatment trial for Locoregionally Advanced Laryngo-hypopharyngeal Squamous Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male/female patients aged≥18 years.
Histologically confirmed Laryngo-hypopharyngeal squamous cell cancer, previously untreated (including surgery/radiotherapy/chemotherapy/immunotherapy).
Locoregionally-advanced disease stage cT2-4N0-3M0.
ECOG performance status 0 to 1.
Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml).
Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

Pregnancy or children bearing potential.
Metastasis.
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer
Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 6 months;
With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).
With uncontrollable complications
Inadequate organ function
known hypersensitivity reaction to any of the study drugs or components.
Other unsuitable conditions determined by investigators.

Sites / Locations

Department of Oncology, Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

5-Fluorouracil(750 mg/m2/d, CIV d1-5) Cisplatin(75mg/m2,d1)/Carboplatin(AUC5, d1) Toripalimab 240mg d1

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Duration of response

Progression free survival rate at 12 months

Laryngo-preservation rate at 12 months

Overall survival rate at 24 months

Safety: adverse events as assessed by CTCAE v5.

Full Information

NCT ID

NCT04926753

First Posted

June 9, 2021

Last Updated

June 14, 2021

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04926753

Brief Title

Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer

Official Title

Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a non-randomized phase 1, open-labeled clinical study, 1-arm, single center, to observe efficacy and safety of chemotherapy plus PD-L1 antibody Toripalimab every 21 days for 2 cycles as induction regimen in locoregionally-advanced laryngo-hypopharyngeal squamous cell cancer patients.

Detailed Description

Locoregionally advanced laryngo-hypopharyngeal squamous cell cancer patients have the demand of laryngo-preservation. Induction chemotherapy (FP) combined with Toripalimab (a humanized IgG4 monoclonal antibody against PD-1) will be given. This regimen will be given every 21 days for 2 cycles. Radiological examinations and PET(FDG/FAPI) examinations pre/post-treatment will be administrated for response evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locoregionally Advanced Laryngo-hypopharyngeal Squamous Cell Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

5-Fluorouracil(750 mg/m2/d, CIV d1-5) Cisplatin(75mg/m2,d1)/Carboplatin(AUC5, d1) Toripalimab 240mg d1

Intervention Type

Drug

Intervention Name(s)

5-Fluorouracil, Cisplatin, Toripalimab

Intervention Description

Drug: FP combined with Toripalimab Combination drugs: 5-Fluorouracil(F), Cisplatin/Carboplatin(P) and Toripalimab every 21 days for 2 cycles This is a single-arm study with all patients receiving these three drugs.

Primary Outcome Measure Information:

Title

Objective response rate

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Duration of response

Time Frame

36 months

Title

Progression free survival rate at 12 months

Time Frame

12 months

Title

Laryngo-preservation rate at 12 months

Time Frame

12 months

Title

Overall survival rate at 24 months

Time Frame

24 months

Title

Safety: adverse events as assessed by CTCAE v5.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male/female patients aged≥18 years. Histologically confirmed Laryngo-hypopharyngeal squamous cell cancer, previously untreated (including surgery/radiotherapy/chemotherapy/immunotherapy). Locoregionally-advanced disease stage cT2-4N0-3M0. ECOG performance status 0 to 1. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml). Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form. Exclusion Criteria: Pregnancy or children bearing potential. Metastasis. Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 6 months; With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone). With uncontrollable complications Inadequate organ function known hypersensitivity reaction to any of the study drugs or components. Other unsuitable conditions determined by investigators.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chengfang Shangguan, MD & Ph.D

Phone

+862164741635

sgcf11674@rjh.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingliang Xiang, MD & Ph.D

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph.D

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Ruijin Hospital

City

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph. D

Phone

+86-13818332497

junzhang10977@sjtu.edu.cn

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph. D

12. IPD Sharing Statement

Learn more about this trial

Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer

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