Adjuvant Sintilimab Plus Capecitabine in Nasopharyngeal Carcinoma

May 6, 2026 updated by: Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

A Randomized, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Sintilimab Plus Capecitabine Versus Capecitabine Alone as Adjuvant Therapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Currently, although NCCN (National Comprehensive Cancer Network) guidelines recommend induction chemotherapy combined with concurrent chemoradiotherapy as IIA level-evidenced treatment for nasopharyngeal carcinoma (NPC), there are still about 20-30% of patients with NPC who experienced recurrence and metastasis after radical treatment.

Our previous results showed that patients with plasma Epstein-Barr virus (EBV) DNA > 0 copy/mL or stable disease/progressive disease (SD/PD) after induction chemotherapy had a significantly higher risk of disease progression than patients with plasma EBV DNA=0 copy/mL and complete response/partial response (CR/PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). As for these high-risk patients, the urgent clinical problem to be solved is whether increased adjuvant treatment intensity after concurrent chemoradiotherapy can improve their survival rates.

The addition of adjuvant capecitabine to chemoradiotherapy significantly improved survival in patients with NPC, with a manageable safety profile. Sintilimab is a humanized monoclonal antibody against programmed death 1(PD-1). Anti-PD-1 monoclonal antibody showed efficacy and safety in previous studies, however, the efficacy of immunotherapy alone was limited. Several prospective studies have shown that anti-PD-1 monoclonal antibody combined with chemotherapy had a synergistic effect.

Based on this, this randomized clinical trial determining whether adjuvant Sintilimab plus Capecitabine versus Capecitabine alone can improve the progression-free survival rate of patients with unfavorable response to induction chemotherapy and may provide new evidence for individualized comprehensive treatment of NPC patients.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III.
  2. Tumor staged as II-IVa (AJCC 8th,excluding T2N0 disease).
  3. Age ≥ 18 years and ≤ 70 years, both genders.
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  5. Patients with plasma EBV DNA> 0 copy/mL or PD/SD according to RECIST1.1 after two cycles of induction chemotherapy.
  6. 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).
  7. Completion of the last radiation dose within 1 to 7 days before randomization
  8. No progression after prior cCRT
  9. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
  10. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
  11. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
  12. Patients must be informed of the investigational nature of this study and give written informed consent.
  13. 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.

Exclusion Criteria:

  1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
  2. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
  3. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
  4. Is pregnant or breastfeeding.
  5. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3 copies/ml or 200IU/ml
  6. Hepatitis C virus (HCV) antibody positive
  7. 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).
  8. 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.
  9. 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.
  10. Has known allergy to large molecule protein products or any compound of sintilimab.
  11. Has a known history of interstitial lung disease.
  12. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjuvant Sintilimab Plus Capecitabine
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
Sintilimab is a humanized monoclonal antibody against Programmed death 1(PD-1).
Other Names:
  • Anti-PD-1 Antibody
  • IBI308
Drug: Capecitabine
An oral anticancer agent that can be converted into 5-Fu in vivo.
Active Comparator: Adjuvant Capecitabine
Capecitabine 1000 mg/m2, BID, D1-14, every three weeks, a total of 24 weeks, 8 cycles.
Drug: Capecitabine
An oral anticancer agent that can be converted into 5-Fu in vivo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress-free survival (PFS)
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of adverse events (AEs)
Time Frame: 2 years
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
2 years
Overall Survival (OS)
Time Frame: 2 years
Defined as the time from random assignment to death from any cause or censored at the date of last follow-up
2 years
Locoregional Relapse-Free Survival (LRFS)
Time Frame: 2 years
Defined as the time from random assignment to local or regional relapse, or death from any cause.
2 years
Distant Metastasis-Free Survival (DMFS)
Time Frame: 2 years
Defined as the time from random assignment to distant metastasis, or death from any cause.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Actual)

March 2, 2026

Study Completion (Estimated)

March 2, 2029

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-FXY-486

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nasopharyngeal Carcinoma

Clinical Trials on Sintilimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe