PD-1 Antibody Sintilimab Combined With Capecitabine as Adjuvant Therapy for High-Risk Nasopharyngeal Carcinoma

NCT06900218 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025-FXY-001-FLK
• Study Type: interventional
• Target: 664
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll 664 patients who had completed induction chemotherapy combined with the PD-1 antibody sintilimab treatment followed by concurrent cisplatin-based chemoradiotherapy (no concurrent sintiliamb). Patients will be randomly divided into two groups. One group will receive 9 cycles of sintilimab therapy, while the other group will receive an additional year of capecitabine chemotherapy on top of the sintilimab treatment. The primary endpoints will be event-free survival and overall survival.

Conditions

Nasopharyngeal Carcinoma (NPC)

Outcome Measures

Primary Outcomes (2)

• Event-free survival (EFS)

  3-years

• Overall survival (OS)

  5-years

Secondary Outcomes (6)

• Distant metastasis-free survival (DMFS)

  3-years

• Locoregional recurrence-free survival (LRFS)

  3-years

• Adverse events (AEs) and serious adverse events (SAEs)

  5-years

• Quality of life (QoL)

  5-years

• Event-free survival (EFS) within different subgroups

  3-years

Study Arms (2)

Sintilimab Combined with Capecitabine

EXPERIMENTAL

Drug: Sintilimab; Drug: Capecitabine

Sintilimab

ACTIVE COMPARATOR

Drug: Sintilimab

Interventions

Sintilimab DRUG

Sintilimab 200 mg, administered on Day 1, every 3 weeks for a total of 9 cycles

Also known as: IBI308, PD-1 antibody

Sintilimab; Sintilimab Combined with Capecitabine

Capecitabine DRUG

Capecitabine 650 mg/m², taken orally twice daily, continuously from Day 1 to Day 21, every 3 weeks, for a maximum of 1 year.

Sintilimab Combined with Capecitabine

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 65 years.
• ECOG performance status of 0-1.
• Newly diagnosed nasopharyngeal carcinoma confirmed by pathological examination of the primary lesion.
• Staging is classified as T4N1M0 or T1-4N2-3M0 according to the 9th Edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
• Must have received recommended radical radiochemotherapy and sintilimab: 3 cycles of gemcitabine combined with cisplatin and Sintilimab; radical intensity-modulated radiotherapy with a total dose of 6,996 cGy over 33 fractions, concurrently receiving 2 cycles of cisplatin at 100 mg/m².
• Completed the last radiation treatment within 2 weeks before randomization.
• neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin concentration ≥ 90g/L, platelet count ≥ 100 × 10⁹/L.
• Total bilirubin ≤ 1.5 times the upper limit of normal; AST and/or ALT ≤ 2.5 times the upper limit of normal; creatinine clearance ≥ 50 mL/min.
• Participants must sign an informed consent form and be willing and able to comply with the study's visit, treatment regimen, laboratory tests, and other requirements.
• Female participants of childbearing potential and male participants with fertile partners must agree to use reliable contraception (such as condoms, or physician-recommended contraceptive pills) from screening to one year post-treatment.

You may not qualify if:

• Active, known, or suspected autoimmune diseases. Participants with Type I diabetes, hypothyroidism requiring only hormone replacement therapy, or skin diseases (e.g., vitiligo, psoriasis, or alopecia) that do not require systemic treatment can be included.
• Severe immune-related adverse events that occurred during the initial Sintilimab induction treatment, as judged by the investigator, preventing continued adjuvant treatment with Sintilimab.
• Received any non-diagnostic surgeries or other targeted, immune, or biological therapies for nasopharyngeal carcinoma except the recommended radiochemotherapy and Sintilimab treatment before randomization.
• factors affecting oral medication (e.g., swallowing difficulties, chronic diarrhea, bowel obstruction).
• Disease progression post-radical radiotherapy.
• Positive HBsAg with HBV DNA \> 200 IU/ml or 1000 copies/ml.
• Positive HCV antibody.
• Active tuberculosis. Patients with active tuberculosis within the past year are excluded, even if treated; patients with a history of active tuberculosis over one year ago are also excluded unless they can prove they have undergone standard anti-tuberculosis therapy.
• History of interstitial lung disease.
• Received a live vaccine within 30 days before informed consent or is scheduled to receive one.
• HIV infection.
• Current or previous malignancies, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma.
• Pregnant or breastfeeding women; pregnancy tests should be considered for sexually active women of childbearing potential.
• Other diseases or conditions assessed by the investigator that may jeopardize patient safety or compliance, such as unstable cardiac diseases, renal diseases, chronic hepatitis, poorly controlled diabetes, psychiatric disorders, severely abnormal laboratory results, or other family or social high-risk factors.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

sintilimab; spartalizumab; 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

Central Study Contacts

Xu Liu, MD

CONTACT

8687343500; liux325@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 28, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2033
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: For 2 years, it started 24 months after the primary trial report was published.
• Access Criteria: Authoritative researchers who provide a methodologically sound proposal for individual participant data meta-analysis.

Locations

CN (1)