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RadiotherapyPhase 2NCT05290194

Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma

A Phase 2 study testing SBRT radiotherapy + Conventionally fractionated radiotherapy, PD-1 inhibitor and Capecitabine in people with Radiotherapy and PD-1 Inhibitor, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Radiotherapy, PD-1 Inhibitor, Capecitabine
What is being tested?
SBRT radiotherapy + Conventionally fractionated radiotherapy, PD-1 inhibitor and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
28 Mar 2022to 31 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient was histologically or cytologically diagnosed with nasopharyngeal carcinoma;
  • The patient was newly diagnosed with metastatic nasopharyngeal carcinoma (AJCC eighth edition), and after 4-6 cycles of gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen, the efficacy reached more than stable disease;
  • Except for the primary tumor and cervical lymph node metastasis, less than 5 distant organ metastases, and were suitable for SBRT radiotherapy;
  • ECOG PS score 0-2 points;
  • Aged 18-70 years old;
  • Major organ function met the following criteria (14 do not allow the use of any blood components and cell growth factor):
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  • Neutrophil ANC ≥ 2.0 × 10^9/L; platelet count PLT ≥ 100 × 10^9/L; hemoglobin HB ≥ 90 g/L;
  • Serum albumin ≥ 28 g/L;
  • Alanine aminotransferase ALT, aspartate aminotransferase AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN;
  • Serum creatinine ≤ 1.5 × ULN, Or creatinine clearance ≥ 60 mL/min;
  • INR ≤ 1.5 × ULN, and APTT ≤ 1.5 × ULN;
  • Life expectancy ≥ 12 weeks;
  • The subject who voluntarily joins the study, sign informed consent, and coordinates with follow-up.

Who cannot join

  • Recurrent and metastatic nasopharyngeal carcinoma after initial treatment;
  • Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments;
  • Central nervous system metastastic (confirmed or suspected);
  • Allergy to PD-1 monoclonal antibody or other PD-1 monoantibody; intolerance or allergy to capecitabine; suffering any disease or extrinsic factors affecting oral drugs;
  • Uncontrolled cardiac clinical symptoms or diseases, such as: ① heart failure of NYHA Grade II or higher ; ② unstable angina pectoris; ③ suffering myocardial infarction within 1 year; ④ patients with supraventricular or arrhythmia requiring clinical intervention;
  • Severe infection (CTCAE 5.0 ≥ 2) 4 weeks before the first use of study drugs, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization; baseline chest imaging examination suggests the presence of active pulmonary inflammation; symptoms and signs of infection or the need for oral or intravenous antibiotics (excluding the prophylactic use of antibiotics) 2 weeks before the first use of the study drug;
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  • History of other malignancies within 5 years or at the time,but except for cured cutaneous basal cell carcinoma and cervical carcinoma in situ, breast carcinoma in situ, superficial bladder tumors (Ta, Tis and T1) and papillary thyroid cancer as well as other cancers treated more than 3 years before the start of the study;
  • Any of the following conditions is met:
  • Received any investigational drug before the first use of the study drug;
  • Participated in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or interventional clinical study at the follow-up time;
  • Required systemic treatments with corticosteroids (the dose higher than the equivalent dose of 10 mg prednisone per day) or other immunosuppressive agents 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergy and nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticotropic hormone replacement at doses greater than 10 mg daily in prednisone efficacy dose are allowed;
  • Received anti-tumor vaccines or vaccinated live vaccines 4 weeks before the first dose of study drug;
  • Underwent excessive surgery or severe trauma 4 weeks before the first use of study drug;
  • Patients had active autoimmune diseases and a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes) in the past 2 years; patients who did not require any intervention after adulthood are allowed;
  • History of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation;
  • Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection 1 year ago but without regular treatment;
  • Patients with active hepatitis (HBV ≥ 2000 IU/ml or HBV DNA ≥ 10000/ml), or hepatitis C (hepatitis C antibody positive, and HCV-RNA ≥ 1000/ml);
  • Patients with coagulation abnormalities (PT > 16s, APTT > 43s, TT > 21s, Fbg < 2 g/L), bleeding tendency or receiving thrombolytic or anticoagulant therapy; or patients with previous severe bleeding (bleeding > 30ml within 3 months), hemoptysis (bleeding > 5ml within 4 weeks) within 12 months due to thromboembolic events (including stroke events and/or transient ischemic attack);
  • Uncontrolled hypertension (systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg); coronary heart disease, arrhythmia ≥ grade II (including QTc prolongation, male > 450 ms, female > 470 ms) and heart failure;
  • Urine protein ≥ + +, or 24 hour urine protein ≥ 1.0 g;
  • Current diarrhea-related diseases (e.g., ulcerative colitis, Crohn's disease, chronic diarrhea, etc.);
  • Known history of psychotropic drug abuse, alcoholism and drug abuse; or current history of antiepileptic drug use;
  • Pregnant or lactating;
  • Patients considered unsuitable for inclusion by the investigator as assessed by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fifth Affilliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong

Other trials in China

About this study

Official title: Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial

This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.

Read the detailed description

This is a single-arm, multicenter, prospective, open-label phase II clinical study of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy for oligometastatic nasopharyngeal carcinoma. Its primary objective is to assess the efficacy, including progression-free survival (PFS), 2-year overall survival (Two-year OS) and progression-free survival (Two-year PFS), overall survival (OS), duration of response (DOR) and safety of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy in treating oligometastatic nasopharyngeal carcinoma. The secondary objective is to explore the potential genetic biomarkers and clinical therapeutic efficacy evaluation and prediction model of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma, providing the evidence of the screening of the potential patients benefiting from the regimen of this trial.

Being tested
SBRT radiotherapy + Conventionally fractionated radiotherapy, PD-1 inhibitor, Capecitabine
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • SBRT radiotherapy + Conventionally fractionated radiotherapyRadiation

    Radiotherapy was performed 3-6 weeks after the end of first-line treatment, followed by conventional fractionated radiotherapy of the primary tumor and cervical lymph node metastases, SBRT radiotherapy of distant organ metastases 3-6 weeks later.

  • PD-1 inhibitorDrug

    Also called Immune Checkpoint Inhibitors

    Immunotherapy of PD-1 inhibitor is used during the whole time of this trial until subjects were withdrawn from the trial or the trial complete

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine is treated for patients 3-6 weeks after radiotherapy, which combines with PD-1 inhibitor as the maintenance regimen in the trial.

Study groups in NCT05290194
Study groupRoleWhat they receive
Oligometastatic nasopharyngeal carcinomaExperimentalPatients included are going to receive radiotherapy, chemotherapy and immunotherapy. Radiotherapy includes IMRT and SBRT. IMRT is applied for primary sites and cervical lymph nodes，and SBRT following is applied for oligometastatic sites. PD-1 inhibitors: during the whole trial, intravenous, Q3W; Capecitabine: 650mg, po, bid, following the radiotherapy for a year.
Receives: Radiation: SBRT radiotherapy + Conventionally fractionated radiotherapy; Drug: PD-1 inhibitor; Drug: Capecitabine

What is being measured

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

  1. Progress-free survival

    The time between enrollment and progression(in any way) or death (for any reason)

    Measured: 2 years

Secondary outcomes (2)

  1. Overall survival

    Time from randomization to death (for any reason)

    Measured: 2years

  2. Duration of response

    Time from the first evaluation of the tumor as CR or PR to the first evaluation as PD or death from any cause

    Measured: 2 yaers

Timeline

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

  1. First posted22 Mar 2022
  2. Study start28 Mar 2022
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Why it stopped: The study was terminated because the protocol was upgraded after being considered insufficiently advanced.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05290194
Sponsor's protocol ID
ZDWY[2022]LunziNo.(K11-1)
Status last verified
Sep 2026
First submitted
5 Mar 2022
Last updated
23 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT radiotherapy + Conventionally fractionated radiotherapy, PD-1 inhibitor and Capecitabine in people with Radiotherapy and PD-1 Inhibitor, run by Fifth Affiliated Hospital, 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 13 inclusion and 24 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: withdrawn, as of the sponsor's last update on 23 Sep 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress-free survival (time frame: 2 years). 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 NCT05290194.

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 23 Sep 2026.

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