A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC

NCT04992559 | Recruiting Phase 2

• 1 other identifier: 2021-KY-039
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).

Conditions

Head and Neck Squamous Cell Carcinomas

Outcome Measures

Primary Outcomes (1)

• 2-year Disease-Free Survival Rate

  The 2-year DFS rate was defined as the rate of progression or death due to disease recurrence within 2 years.

  2 years

Secondary Outcomes (4)

• 2-year overall survival rate

  2 years

• Media Disease-free Survival (mDFS)

  Up to 5 years

• Overall survival

  5 years

• Adverse events

  90 days after the first dose of study treatment

Study Arms (1)

Toripalimab Arm

EXPERIMENTAL

Toripalimab consolidation therapy

Drug: Consolidation Toripalimab

Interventions

Consolidation Toripalimab DRUG

Toripalimab consolidation therapy after radiotherapy or chemoradiotherapy, 240mg IV, every 3 weeks, until progressive disease (PD), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Toripalimab will be given at a maximum of 12 months.

Toripalimab Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postoperative with adverse prognostic factors in patients with locally advanced head and neck squamous cell carcinoma.
• Have received postoperative adjuvant radiotherapy (chemo) therapy, and the end of the treatment is not more than 2 months.
• Greater than or equal to 18 and less than 70 years of age at time of study entry.
• ECOG performance status of 0 or 1.
• Measurable disease as per RECIST 1.1.
• Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
• Adequate hepatic and renal function as demonstrated by
• Serum creatinine \< 1.5 X ULN or CrCl \> 40mL/min (if using the Cockcroft-Gault formula below):
• Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL)）
• Females: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL))x 0.85
• AST/ALT ≤ 3 x ULN
• Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
• Adequate bone marrow function as demonstrated by:
• Absolute Neutrophil Count \>1,500/µL
• Platelets \> 100 X 103/µL

You may not qualify if:

• Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had another known invasive malignancy within the previous 5 years （With the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid, which has been cured）.
• If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Active, known or suspected autoimmune disease.
• Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
• Has an active infection requiring systemic therapy.
• Has received prior therapy with an anti-PD-1 antibody .
• A history of allergic reaction attributed to compounds of similar chemical or biologic composition to the treatment or other agents used in the study.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
• Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
• Has known active Hepatitis B or C.
• Known history of active TB ( bacillus tuberculosis ).

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (2)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Song Fan, Doctor degrees

CONTACT

13570536658; fansong2@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: June 22, 2021
• Primary Completion: December 1, 2024
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

CN (2)