Neoadjuvant Chemotherapy Plus Tislelizumab Followed by Concurrent Chemoradiotherapy and Maintenance Therapy With Tislelizumab in Patients With Stage IVA Nasopharyngeal Carcinoma: A Single-arm, Phase II Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
RECRUITING
Beijing
Contact Information
Primary
Shiran Sun, Dr.
cindy899@126.com
+86 10 67781331
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Experimental: GP combined with Tislelizumab neoadjuvant therapy+CCRT+Tislelizumab adjuvant therapy
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
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov