Adjuvant Sintilimab Plus Capecitabine in Nasopharyngeal Carcinoma

NCT05201859 | Active Not Recruiting Phase 2

• 1 other identifier: 2021-FXY-486
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial determining whether Sintilimab plus Capecitabine versus Capecitabine alone can improve the progression-free survival rate of NPC patients with unfavorable response to induction chemotherapy. Patients whose plasma EBV DNA\> 0 copy/mL or SD/PD according to RECIST1.1 after two cycles induction chemotherapy will have concurrent chemoradiotherapy. MRI, CT and EBV DNA will be assessed before the end of radiotherapy. After concurrent chemoradiotherapy, eligible patients will be randomized to receive either adjuvant Sintilimab plus Capecitabine or Capecitabine alone.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progress-free survival (PFS)

  Defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.

  2 years

Secondary Outcomes (4)

• Overall Survival (OS)

  2 years

• Locoregional Relapse-Free Survival (LRFS)

  2 years

• Distant Metastasis-Free Survival (DMFS)

  2 years

• Incidence rate of adverse events (AEs)

  2 years

Study Arms (2)

Adjuvant Sintilimab Plus Capecitabine

EXPERIMENTAL

Lead-in Phase: Sintilimab (200mg, D1, D14 for 2 cycles); Adjuvant Phase: Sintilimab ( 200mg D1, every three weeks, a total of 24 weeks, 8 cycles) + Capecitabine ( 1000 mg/m2, BID, D1-14 every three weeks, a total of 24 weeks, 8 cycles).

Drug: Sintilimab; Drug: Capecitabine

Adjuvant Capecitabine

ACTIVE COMPARATOR

Capecitabine 1000 mg/m2, BID, D1-14, every three weeks, a total of 24 weeks, 8 cycles.

Drug: Capecitabine

Interventions

Sintilimab DRUG

Sintilimab is a humanized monoclonal antibody against Programmed death 1(PD-1).

Also known as: Anti-PD-1 Antibody, IBI308

Adjuvant Sintilimab Plus Capecitabine

Capecitabine DRUG

An oral anticancer agent that can be converted into 5-Fu in vivo.

Adjuvant Capecitabine; Adjuvant Sintilimab Plus Capecitabine

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III.
• Tumor staged as II-IVa (AJCC 8th,excluding T2N0 disease).
• Age ≥ 18 years and ≤ 70 years, both genders.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
• Patients with plasma EBV DNA\> 0 copy/mL or PD/SD according to RECIST1.1 after two cycles of induction chemotherapy.
• Completed protocol-specified curative chemoradiotherapy, including two cycles of induction chemotherapy, intensity-modulated radiotherapy, and concurrent cisplatin chemotherapy( at least 2 cycles of concurrent cisplatin chemotherapy).
• Completion of the last radiation dose within 1 to 7 days before randomization
• No progression after prior cCRT
• Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
• Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
• Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
• Patients must be informed of the investigational nature of this study and give written informed consent.
• Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.

You may not qualify if:

• Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
• Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
• Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
• Is pregnant or breastfeeding.
• Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1×10e3 copies/ml or 200IU/ml
• Hepatitis C virus (HCV) antibody positive
• Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
• Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
• Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.
• Has known allergy to large molecule protein products or any compound of sintilimab.
• Has a known history of interstitial lung disease.
• Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

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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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: January 21, 2022
• Study Start: May 17, 2022
• Primary Completion: March 2, 2026
• Study Completion (Estimated): March 2, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

CN (1)