Toripalimab Plus TPF Chemotherapy and Radiotherapy for LA-HPSCC

NCT ID: NCT04624308

Last Updated: 2020-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2025-12-30

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.

Conditions

Hypopharyngeal Neoplasm Malignant Primary

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TPF inductive chemotherapy plus Toripalimab and radiotherapy plus Toripalimab

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.

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

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

Interventions

Toripalimab

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

Intervention Type: DRUG

Other Intervention Names

Tuoyi

Eligibility Criteria

Inclusion Criteria

1. 18y ≤age≤65y;

2. ECOG：0-1；

3. Histology：squamous cell carcinoma, located in hypopharynx;

4. 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.

5. never received any previous treatment, including radiotherapy, chemotherapy, or immune therapy, et al.

6. at least one measurable lesion (RECIST 1.1 criteria).

7. expected survival ≥6 months.

8. no contraindications of radiotherapy, chemotherapy and immune therapy.

9. 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

10. contraception

11. voluntary and compliance.

Exclusion Criteria

1. other histology cancers located in hypopharynx.

2. synchronous or metachronous cancers located in other sites.

3. allergy to monoclonal antibody.

4. uncontrollable heart disease or symptoms.

5. uncontrollable infections.

6. fever of unknown origin>38.5℃ during screening or before administration.

7. active autoimmune disease.

8. history of immunodeficiency disorders, including HIV.

9. active HBV or HCV.

10. history of interstitial lung disease.

11. active tuberculosis.

12. 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.

13. uncontrollable hypertension.

14. uncontrollable type 2 diabetes；

15. hemorrhagic tendency.

16. drug or alcoholic abuse.

17. woman during pregnancy or lactation period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: collaborator

Sun Yan

OTHER

Sponsor Role: lead

Responsible Party

Sun Yan

Principal Investigator, Chief of Head and Heck Group of Radiotherapy Department, Peking University Cancer Hospital, Peking University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yan Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yan Sun, MD

Role: CONTACT

Phone: 0086-10-88196217

Email: lisaysun@139.com

Facility Contacts

Yan Sun, MD

Role: primary

Other Identifiers

2020-JS001-HPSCC

Identifier Type: -

Identifier Source: org_study_id