Toripalimab Plus TPF Chemotherapy and Radiotherapy for LA-HPSCC

NCT04624308 | Unknown Phase 2 DMC

• 1 other identifier: 2020-JS001-HPSCC
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypopharyngeal Neoplasm Malignant Primary

Keywords

hypopharyngeal carcinoma; radiotherapy; inductive chemotherapy; PD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• Complete remission rate

  Complete remission rate 3 months after treatment

  3 months after treatment

Secondary Outcomes (4)

• ORR

  3 months after treatment

• DCR

  5 year

• PFS

  5 year

• OS

  5 year

Study Arms (1)

TPF inductive chemotherapy plus Toripalimab and radiotherapy plus Toripalimab

EXPERIMENTAL

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.

Drug: Toripalimab

Interventions

Toripalimab DRUG

Toripalimab 240mg d1，Q3W. Given with TPF during inductive chemotherapy and definitive radiotherapy.

Also known as: Tuoyi

TPF inductive chemotherapy plus Toripalimab and radiotherapy plus Toripalimab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• y ≤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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Sun Yan: lead
• Shanghai Junshi Bioscience Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Hypopharyngeal Neoplasms

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Yan Sun, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Sun, MD

CONTACT

0086-10-88196217; lisaysun@139.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Chief of Head and Heck Group of Radiotherapy Department, Peking University Cancer Hospital, Peking University

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 10, 2020
• Study Start: October 30, 2020
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)