AzTrials
AzTrials

Nasopharyngeal Carcinoma (NPC)Phase 3NCT06900218

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

A Phase 3 study testing Sintilimab and Capecitabine in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Carcinoma (NPC)
What is being tested?
Sintilimab and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
664 participants
Where
1 siteChina
Study dates
1 May 2025to 1 May 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • Positive HCV antibody.
  • Received systemic corticosteroids or other immunosuppressive therapy at equivalent doses > 10 mg of prednisone/day within 28 days before informed consent. Patients on systemic corticosteroids ≤ 10 mg of prednisone/day or inhaled/topical corticosteroids can be included. Using corticosteroids to manage or prevent treatment-related toxicity is permissible for inclusion.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xu Liu, MD contact

8687343500

liux325@mail.sysu.edu.cn

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, China, 510060

    Xu Liu, MD, 8687343500, liux325@mail.sysu.edu.cn

Other trials in China

About this study

Official title: A Multicenter, Randomized Controlled Phase III Trial of Sintilimab Combined With Capecitabine Versus Capecitabine Alone as Adjuvant Therapy for High-Risk Locoregionally-advanced Nasopharyngeal Carcinoma

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.

Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SintilimabDrug

    Also called IBI308, PD-1 antibody

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

  • CapecitabineDrug

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

Study groups in NCT06900218
Study groupRoleWhat they receive
Sintilimab Combined with CapecitabineExperimentalNot described
Receives: Drug: Sintilimab; Drug: Capecitabine
SintilimabActive comparatorNot described
Receives: Drug: Sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS)

    Measured: 3-years

  2. Overall survival (OS)

    Measured: 5-years

Secondary outcomes (6)

  1. Distant metastasis-free survival (DMFS)

    Measured: 3-years

  2. Locoregional recurrence-free survival (LRFS)

    Measured: 3-years

  3. Adverse events (AEs) and serious adverse events (SAEs)

    Measured: 5-years

  4. Quality of life (QoL)

    The change of QoL from randomization to 9 weeks (at the 3rd cycle of adjuvant sintilimab treatment), 1 year, 2 years, 3 years, 4 years, and 5 years after randomization. The EORTC QoL questionnaire-C30 (EORTC QLQ-C30) version 3.0 will be used. This questionnaire comprises 30 questions, 24 aggregated into nine multi-question scales: five functioning scales (e.g., physical), three symptom scales (e.g., fatigue), and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual of EORTC QLQ-C30.

    Measured: 5-years

  5. Event-free survival (EFS) within different subgroups

    analyses for EFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (=0 vs. >0copies/ml after radiotherapy), different PD-L1 CPS (0 vs. ≥1), tertiary lymphoid structure (+ vs. -), age, sex, performance status, T category, N category, and stage (II vs. III).

    Measured: 3-years

  6. Overall survival (OS) within different subgroups

    analyses for OS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (=0 vs. >0copies/ml after radiotherapy), different PD-L1 CPS (0 vs. ≥1), tertiary lymphoid structure (+ vs. -), age, sex, performance status, T category, N category, and stage (II vs. III).

    Measured: 5-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion1 May 2030 (estimated)
  4. Study completion1 May 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
664 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06900218
Sponsor's protocol ID
2025-FXY-001-FLK
Status last verified
Mar 2025
First submitted
20 Mar 2025
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Complete de-identified patient data set

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sintilimab and Capecitabine in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xu Liu, MD (8687343500, liux325@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (EFS) (time frame: 3-years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06900218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in