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

NCT ID: NCT05420597

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-07
• Study Completion Date: 2025-12-31

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.

Conditions

Laryngeal Cancer; Hypopharyngeal Cancer

Study Design

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

Study Groups

Induction chemotherapy and Toripalimab

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

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

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).

Interventions

Toripalimab

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).

Intervention Type: DRUG

Other Intervention Names

JS001

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xiayun He, MD

M.D., Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiayun He, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Yu Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiayun He, M.D.

Role: CONTACT

hexiayun1962@126.com

(86)021-64175590 ext. 81400

Yu Wang, M.D.

Role: CONTACT

Facility Contacts

Xiayun He, MD

Role: primary

hexiayun1962@126.com

+86-18017312167

Xiaomin Ou, MD

Role: backup

0456218@fudan.edu.cn

+86-18017317872

Other Identifiers

INSIGHT-2

Identifier Type: -

Identifier Source: org_study_id