Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma

NCT07373990 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025-FXY-462-FLK
• Study Type: interventional
• Target: 418
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the consolidation phase) in patients with locoregionally advanced nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Cancer; Nasopharyngeal Cancinoma (NPC)

Keywords

tislelizumab; PD-1 antibody; short-course

Outcome Measures

Primary Outcomes (1)

• Failure-free survival (FFS)

  From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.

  3 years

Secondary Outcomes (6)

• Overall survival (OS)

  3 years

• Distant metastasis-free survival (DMFS)

  3 years

• Locoregional recurrence-free survival (LRRFS)

  3 years

• Adverse events (AEs)

  within 5 years

• Quality of life (QoL)

  week 0, 9, 16, 28, 40 and 1 year, 2 years, 3 years, 4 years, and 5 years after randomization

Study Arms (2)

tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant)

EXPERIMENTAL

Patients will receive neoadjuvant gemcitabine (1000 mg/m2 d1, d8), cisplatin (80 mg/m2 d1) and tislelizumab (200 mg) every 3 weeks for 3 cycles, followed by defnitive intensitymodulated radiotherapy (IMRT) of 6996cGy in 33 fractions. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Subsequently, adjuvant therapy with tislelizumab (400 mg) every 6 weeks for 3 cycles.

Drug: tislelizumab; Drug: Gemcitabine + cisplatin (GP); Drug: Cisplatin (100mg/m2); Radiation: intensity-modulated radiotherapy

tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant)

ACTIVE COMPARATOR

Patients will receive neoadjuvant gemcitabine (1000 mg/m2 d1, d8), cisplatin (80 mg/m2 d1) and tislelizumab (200 mg) every 3 weeks for 3 cycles, followed by defnitive intensitymodulated radiotherapy (IMRT) of 6996cGy in 33 fractions. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Subsequently, adjuvant therapy with tislelizumab (400 mg) every 6 weeks for 5 cycles.

Drug: tislelizumab; Drug: Gemcitabine + cisplatin (GP); Drug: Cisplatin (100mg/m2); Radiation: intensity-modulated radiotherapy

Interventions

tislelizumab DRUG

Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 3 cycles.

tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant)

Gemcitabine + cisplatin (GP) DRUG

neoadjuvent gemcitabine (1000 mg/m2 d1, d8) and cisplatin (80 mg/m2 d1) every 3 weeks for 3 cycles

tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant); tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant)

Cisplatin (100mg/m2) DRUG

Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant); tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant)

intensity-modulated radiotherapy RADIATION

Defnitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant); tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 and ≤65 years
• Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
• Eastern Cooperative Oncology Group performance score of 0-1.
• Tumor staged as T4N1 and T1-4N2-3 disease (AJCC 9th edition).
• Adequate marrow function:
• white blood cell count \> 4 × 10⁹/L hemoglobin \>90g/L and platelet count \>100×10⁹/L

You may not qualify if:

• \. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.
• \. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug.
• Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \>1×10 copies/mL, positive for anti-hepatitis C virus (HCV) antibody, positive for anti-hepatitis C virus (HCV) antibody
• Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
• Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received con dirmed and regular anti-tuberculosis treatment.
• Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.
• History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
• Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.
• Uncontrolled cardiac conditions, such as: Heart failure with New York Heart Association (NYHA) classi dication ≥ Class II; or Unstable angina; or History of myocardial infarction within the past year; or Supraventricular or ventricular arrhythmias requiring treatment or intervention
• Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)
• History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
• Known hypersensitivity to macromolecule protein products.
• Active infections requiring systemic treatment within 1 week prior to enrollment.
• Administration of live vaccines within 30 days prior to the first dose of tile.
• History of organ transplantation or hematopoietic stem cell transplantation.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

tislelizumab; Gemcitabine; Cisplatin; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; 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; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Jun Ma

CONTACT

+862087343469; majun2@mail.sysu.edu.cn

Yelin Liang

CONTACT

+862087342370; liangyl@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 28, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share