Neoadjuvant and Adjuvant Tislelizumab for Nasopharyngeal Carcinoma

NCT05448885 | Unknown Phase 2

• 1 other identifier: 21/273-2944
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To estimate the efficacy and safety of tislelizumab for stage IVA locally advanced nasopharyngeal carcinoma combined with induction chemotherapy and concurrent chemoradiotherapy, followed by maintenance therapy

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 2-y PFS

  defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment.

  2 years

Secondary Outcomes (4)

• CR

  1 year

• OS

  3 years

• PFS

  3 years

• safety

  3 years

Study Arms (1)

Experimental: GP combined with Tislelizumab neoadjuvant therapy+CCRT+Tislelizumab adjuvant therapy

EXPERIMENTAL

Patients receive neoadjuvant therapy with gemcitabine(1000mg per square meter on day 1,8) , cisplatin (25mg per square meter on day 1-3) and tislelizumab(200mg) every three weeks for 2 cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100mg per square meter) concurrent every three weeks during radiotherapy ,then followed by adjuvant therapy with tislelizumab(200mg) every three weeks for 13 cycles after radiotherapy

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

Patients receive neoadjuvant therapy with gemcitabine(1000mg per square meter on day 1,8) , cisplatin (25mg per square meter on day 1-3) and tislelizumab(200mg) every three weeks for 2 cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100mg per square meter) concurrent every three weeks during radiotherapy ,then followed by adjuvant therapy with tislelizumab(200mg) every three weeks for 13 cycles after radiotherapy

Also known as: gemcitabine, cisplatin

Experimental: GP combined with Tislelizumab neoadjuvant therapy+CCRT+Tislelizumab adjuvant therapy

Eligibility Criteria

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

You may qualify if:

• The subjects are not limited by gender, age from 18 to 70 years old;
• Histopathologically confirmed non-keratinizing squamous cell carcinoma of the nasopharynx;
• Locally advanced nasopharyngeal squamous cell carcinoma diagnosed as T4 or N3 stage according to AJCC 8th edition staging;
• ECOG score 0-1;
• without distant metastasis;
• This treatment must be the first course of treatment, and has not received any anti-tumor treatment such as radiotherapy and chemotherapy, immune or biological therapy in the past.
• The expected survival is expected to be no less than 6 months.
• No contraindications to chemotherapy, immunotherapy and radiotherapy;

You may not qualify if:

• Received any systemic anti-tumor therapy for target lesions in the past;
• Previously experienced head and neck radiation therapy;
• Those who have received any immunotherapy such as anti-PD-1/PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody in the past;
• Subjects who have been vaccinated with anti-tumor vaccines or other drugs with immunomodulatory functions (such as interleukin-2, thymosin, lentinan, etc.) within 1 month before enrollment, or who will be vaccinated with live attenuated vaccines. subject;
• Subjects who have used corticosteroids (\>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone ≤10 mg/day are permitted;
• Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity effusion drainage for the purpose of treatment within 2 weeks before enrollment;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

tislelizumab; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Shiran Sun, Dr.

CONTACT

+86 10 67781331; cindy899@126.com

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: chief physician

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)