Back to resultsToripalimab Plus TPF Chemotherapy and Radiotherapy for LA-HPSCC
Primary Purpose
Hypopharyngeal Neoplasm Malignant Primary
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Sponsored by
About this trial
This is an interventional treatment trial for Hypopharyngeal Neoplasm Malignant Primary focused on measuring hypopharyngeal carcinoma, radiotherapy, inductive chemotherapy, PD-1 inhibitor
Eligibility Criteria
Inclusion Criteria:
- 18y ≤age≤65y;
- ECOG：0-1；
- Histology：squamous cell carcinoma, located in hypopharynx;
- clinical stage: cT1N1-3M0、cT2-3N0-3M0，organ-preservation-intent regime is made after multidisciplinary treatment(MDT) discussion. Efficacy evaluation will be made according to RECIST 1.1 after inductive chemotherapy, and the following treatment will be chosen according to the results of efficacy evaluation.
- never received any previous treatment, including radiotherapy, chemotherapy, or immune therapy, et al.
- at least one measurable lesion (RECIST 1.1 criteria).
- expected survival ≥6 months.
- no contraindications of radiotherapy, chemotherapy and immune therapy.
- functions of main organs A. WBC≥3.0x109 /L，ANC≥1.5x109/L B. HB≥90g/L C. PLT≥100x109 /L D. serum albumin≥2.8g/dL E. TBil ≤1.5xULN，ALT、AST≤3.0xULN F. serum creatinine ≤1.5xULN or creatinine clearance rate>60mL/min（Cockcroft-Gault） G. APTT and INR ≤1.5xULN
- contraception
- voluntary and compliance.
Exclusion Criteria:
- other histology cancers located in hypopharynx.
- synchronous or metachronous cancers located in other sites.
- allergy to monoclonal antibody.
- uncontrollable heart disease or symptoms.
- uncontrollable infections.
- fever of unknown origin>38.5℃ during screening or before administration.
- active autoimmune disease.
- history of immunodeficiency disorders, including HIV.
- active HBV or HCV.
- history of interstitial lung disease.
- active tuberculosis.
received any drugs listed below: A. received any study drug 4 weeks before first dose of Toripalimab. B. received any anti-cancer drug 4 weeks before first dose of Toripalimab. C. received any glucocorticoids （>10mg prednison per day） 2 weeks before first dose of Toripalimab.
D. received any cancer vaccine 4 weeks before first dose of Toripalimab. E. received any operation or trauma 4 weeks before first dose of Toripalimab. F. recruited in other study.
- uncontrollable hypertension.
- uncontrollable type 2 diabetes；
- hemorrhagic tendency.
- drug or alcoholic abuse.
- woman during pregnancy or lactation period.
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TPF inductive chemotherapy plus Toripalimab and radiotherapy plus Toripalimab
Arm Description
TPF inductive chemotherapy plus Toripalimab for 3 cycles, and radiotherapy plus Toripalimab if the inductive treatment efficacy is CR or >75%PR. If not, operation is suggested.
Outcomes
Primary Outcome Measures
Complete remission rate
Complete remission rate 3 months after treatment
Secondary Outcome Measures
ORR
objective response rate
DCR
disease control rate
PFS
progression free survival
OS
overall survival
Full Information
NCT ID
NCT04624308
First Posted
October 31, 2020
Last Updated
November 5, 2020
Sponsor
Sun Yan
Collaborators
Shanghai Junshi Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04624308
Brief Title
Toripalimab Plus TPF Chemotherapy and Radiotherapy for LA-HPSCC
Official Title
Toripalimab Plus TPF Inductive Chemotherapy and Definitive Radiotherapy for Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Efficacy and Safety: a Phase II Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2020 (Anticipated)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sun Yan
Collaborators
Shanghai Junshi Bioscience Co., Ltd.
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
TPF is the standard regime of inductive chemotherapy for squamous carcinoma of head and neck. If the primary tumor shrinks obviously (complete remission or >75% partial remission )after inductive chemotherapy, CCRT is suggested as the definitive therapy, for the tumor is sensitive to chemotherapy. If the primary tumor shrinks a little or progresses after inductive chemotherapy, operation is suggested as the definitive therapy to get a longer survival.
Detailed Description
Inductive chemotherapy plus CCRT or operation is an option of organ preservation for patients of hypopharyngeal carcinoma. Many clinical studies have demonstrated that inductive chemotherapy plus CCRT achieved the same prognosis as total laryngectomy, and minimized the damage of normal tissue. TPF is the standard regime of inductive chemotherapy for squamous carcinoma of head and neck. If the primary tumor shrinks obviously (complete remission or >75% partial remission )after inductive chemotherapy, CCRT is suggested as the definitive therapy, for the tumor is sensitive to chemotherapy. If the primary tumor shrinks a little or progresses after inductive chemotherapy, operation is suggested as the definitive therapy to get a longer survival. This is a prospective, phase II, cohort study. We designate TPF plus Toripalimab as the inductive regime, expecting a higher complete remission rate and longer PFS and OS. And we replace the CCRT with radiation plus Toripalimab to decrease the adverse events of CCRT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopharyngeal Neoplasm Malignant Primary
Keywords
hypopharyngeal carcinoma, radiotherapy, inductive chemotherapy, PD-1 inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TPF inductive chemotherapy plus Toripalimab and radiotherapy plus Toripalimab
Arm Type
Experimental
Arm Description
TPF inductive chemotherapy plus Toripalimab for 3 cycles, and radiotherapy plus Toripalimab if the inductive treatment efficacy is CR or >75%PR. If not, operation is suggested.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Other Intervention Name(s)
Tuoyi
Intervention Description
Toripalimab 240mg d1，Q3W. Given with TPF during inductive chemotherapy and definitive radiotherapy.
Primary Outcome Measure Information:
Title
Complete remission rate
Description
Complete remission rate 3 months after treatment
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
ORR
Description
objective response rate
Time Frame
3 months after treatment
Title
DCR
Description
disease control rate
Time Frame
5 year
Title
PFS
Description
progression free survival
Time Frame
5 year
Title
OS
Description
overall survival
Time Frame
5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18y ≤age≤65y;
ECOG：0-1；
Histology：squamous cell carcinoma, located in hypopharynx;
clinical stage: cT1N1-3M0、cT2-3N0-3M0，organ-preservation-intent regime is made after multidisciplinary treatment(MDT) discussion. Efficacy evaluation will be made according to RECIST 1.1 after inductive chemotherapy, and the following treatment will be chosen according to the results of efficacy evaluation.
never received any previous treatment, including radiotherapy, chemotherapy, or immune therapy, et al.
at least one measurable lesion (RECIST 1.1 criteria).
expected survival ≥6 months.
no contraindications of radiotherapy, chemotherapy and immune therapy.
functions of main organs A. WBC≥3.0x109 /L，ANC≥1.5x109/L B. HB≥90g/L C. PLT≥100x109 /L D. serum albumin≥2.8g/dL E. TBil ≤1.5xULN，ALT、AST≤3.0xULN F. serum creatinine ≤1.5xULN or creatinine clearance rate>60mL/min（Cockcroft-Gault） G. APTT and INR ≤1.5xULN
contraception
voluntary and compliance.
Exclusion Criteria:
other histology cancers located in hypopharynx.
synchronous or metachronous cancers located in other sites.
allergy to monoclonal antibody.
uncontrollable heart disease or symptoms.
uncontrollable infections.
fever of unknown origin>38.5℃ during screening or before administration.
active autoimmune disease.
history of immunodeficiency disorders, including HIV.
active HBV or HCV.
history of interstitial lung disease.
active tuberculosis.
received any drugs listed below: A. received any study drug 4 weeks before first dose of Toripalimab. B. received any anti-cancer drug 4 weeks before first dose of Toripalimab. C. received any glucocorticoids （>10mg prednison per day） 2 weeks before first dose of Toripalimab.
D. received any cancer vaccine 4 weeks before first dose of Toripalimab. E. received any operation or trauma 4 weeks before first dose of Toripalimab. F. recruited in other study.
uncontrollable hypertension.
uncontrollable type 2 diabetes；
hemorrhagic tendency.
drug or alcoholic abuse.
woman during pregnancy or lactation period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Sun, MD
Phone
0086-10-88196217
Email
lisaysun@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Sun, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Sun, MD
Phone
010-88196217
Email
lisaysun@139.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data is administered by Peking University Cancer Hospital, the investigators need to request related department for sharing IPD.
Learn more about this trial
Toripalimab Plus TPF Chemotherapy and Radiotherapy for LA-HPSCC
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