Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma

NCT05342792 | Recruiting Phase 3 DMC

• 1 other identifier: SL-B2022-202-02
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.

Conditions

Nasopharyngeal Carcinoma

Keywords

PD-1 antibody; Metronomic capecitabine; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• failure-free survival

  calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first

  3 years

Secondary Outcomes (5)

• overall survival

  5 years

• distant metastasis-free survival

  3 years

• locoregional recurrence-free survival

  3 years

• adverse events (AEs) and severe adverse events (SAE)

  5 years

• quality of life (QoL)

  3 years

Study Arms (2)

Metronomic Capecitabine with PD-1 antibody arm

EXPERIMENTAL

Patients randomised to this arm will receive metronomic capecitabine (650mg/m2, BID, PO) and Tislelizuamb (200mg, iv drip, Q3W) for 1 year as adjuvant therapy, beginning 4-6 weeks after chemoradiation.

Drug: PD-1 antibody; Drug: Capecitabine

Metronomic Capecitabine alone arm

ACTIVE COMPARATOR

Patients randomised to this arm will receive metronomic capecitabine (650mg/m2, BID, PO) alone for 1 year as adjuvant therapy, beginning 4-6 weeks after chemoradiation.

Drug: Capecitabine

Interventions

PD-1 antibody DRUG

Tislelizumab：200 mg per dose, intravenous infusion over 30 minutes, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy

Also known as: Tislelizumab

Metronomic Capecitabine with PD-1 antibody arm

Capecitabine DRUG

Capecitabine : 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy

Metronomic Capecitabine alone arm; Metronomic Capecitabine with PD-1 antibody arm

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 at diagnosis: 18 \~ 65 years old;
• Pathologically confirmed primary nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)";
• Locoregionally advanced nasopharyngeal carcinoma (T4N + or TanyN2-3M0, or TanyNanyM0 pretreatment EBVDNA ≥ 4000 copies/mL) was diagnosed according to the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) 8th edition clinical staging system.
• Induction and concurrent chemoradiotherapy with the recommended regimen have been completed;
• ECOG score: 0 \~ 1 points (Appendix II);
• It is recommended to initiate adjuvant therapy within 1 month after the completion of the last radiotherapy treatment, no later than 6 weeks;
• Normal bone marrow function: white blood cell count \> 4 × 109/L, hemoglobin concentration \> 90 g/L, platelet count \> 100 × 109/L;
• Normal liver and kidney function: total bilirubin ≤ 1.5 times the upper limit of normal; aspartate aminotransferase and/or alanine aminotransferase ≤ 2.5 times the upper limit of normal; alkaline phosphatase ≤ 2.5 times the upper limit of normal; creatinine clearance ≥ 60 mL/min;
• Subjects must sign the informed consent form, and must be willing and able to comply with the visits, treatment regimen, laboratory tests and other requirements specified in the study protocol;
• Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use reliable contraception (e.g., condoms, regular contraceptives as directed) from screening through 1 year after treatment.

You may not qualify if:

• Positive hepatitis B surface antigen and hepatitis B virus quantification \> 1 × 1000 copies/ml, or positive anti-hepatitis C virus antibody;
• Positive anti-HIV antibody or diagnosis of acquired immunodeficiency syndrome (i.e., AIDS);
• Conditions such as dysphagia, chronic diarrhea, or bowel obstruction that would interfere with oral medication.
• Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal or antiviral therapy before randomization, including but not limited to tuberculosis infection
• Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchiectasis). Except for type I diabetes, hypothyroidism requiring hormone replacement therapy and skin diseases not requiring systemic treatment (such as vitiligo, psoriasis or alopecia); clinicians should perform necessary history, examination and examination before enrollment for the above diseases and then exclude them;
• Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year;
• Definite clinical evidence of persistent local disease or distant metastasis after chemoradiotherapy;
• Systemic hormonal or other immunosuppressive therapy with an equivalent dose of \> 10 mg prednisone/day within 28 days prior to informed consent. Subjects with systemic sex hormone doses ≤ 10 mg prednisone/day or inhaled/topical corticosteroids may be included.
• Uncontrolled heart disease, such as: 1) heart failure, NYHA level ≥ 2; 2) unstable angina; 3) history of myocardial infarction in the past year; 4) supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
• Pregnant or lactating women (pregnancy test should be considered for sexually active women of childbearing age);
• Previous or current other malignancy other than adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma;
• Receipt of live vaccines within 30 days prior to the first course of tislelizumab;
• History of organ transplantation;
• Other conditions that may jeopardize patient safety or compliance as assessed by the investigator, such as serious illness (including psychiatric disorders) requiring prompt treatment, severely abnormal test results, and other family or social risk factors.
• Patients who received surgical treatment, biological therapy, or immunotherapy during or before radiotherapy;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Tongji Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Xiangya Hospital of Central South University: collaborator
• Affiliated Cancer Hospital of Guizhou Medical University: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator
• First People's Hospital of Foshan: collaborator
• Chongqing University Cancer Hospital: collaborator
• Hubei Cancer Hospital: collaborator
• Hunan Cancer Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Shandong Provincial Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

spartalizumab; tislelizumab; Capecitabine

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)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jun Ma, MD

  Sun Yet-senU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Ma, MD

CONTACT

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

Yuan Zhang, PhD

CONTACT

+862087343469; zhangyuan@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: Hospital Deputy Dean

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 25, 2022
• Study Start: April 17, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 24 months following article publication
• Access Criteria: Proposals should be emailed to the PI to gain access

Locations

CN (1)