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Nasopharyngeal CarcinomaPhase 2NCT05147844

Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

A Phase 2 study testing Toripalimab in people with Nasopharyngeal Carcinoma, run by Xinqiao Hospital of Chongqing at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the study was to determine the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
1 Mar 2022to 1 Mar 2026
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have signed written informed consent and able to comply with study procedure
  • 18-75 years old
  • Histologically or cytologically confirmed nasopharyngeal carcinoma
  • Pathology or imaging confirmed metastatic nasopharyngeal carcinoma.( Clinical stage of IVB according to the 8th edition of AJCC)
  • Imaging (preferred PET-CT) confirmed oligometastatic NPC (defined as ≤5 metastatic lesions, ≤2 metastatic organs)
  • Have not received any treatment for metastatic nasopharyngeal carcinoma.
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  • Unsuitable or unwilling to receive chemotherapy according to the judgment of investigator.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1
  • Estimated life ≥ 6 month
  • At least 1 measurable lesions according to RECIST v1.1
  • Adequate organ function, defined as achieving the following laboratory test results within 7 days before enrollment: ANC≥1.5×10^9/L，PLT≥100×10^9/L，Hb≥90g/L((Have not accepted blood transfusion or growth factors within 14 days)；the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; activated partial thromboplastin time(APTT) ≤1.5 × ULN；serum creatinine≤1.5×ULN or estimated glomerular filtration rate(GFR) ≥ 60 mL/min/1.73 m2; total bilirubin≤1.5×ULN（total bilirubin<3×ULN for patients with Gilbert syndrome）; AST and ALT ≤ 2.5×ULN (AST and ALT ≤ 2.5×ULN for patients with liver metastasis);

Who cannot join

  • Allergy to any component of toripalimab
  • With any active autoimmune disease or a history of autoimmune disease that may relapse
  • Note: Patients with the following diseases were not excluded and should be further screened:
  • Controlled type 1 diabetes; Hypothyroidism (could be controlled just by hormone replacement therapy); Controlled celiac disease; Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, alopecia); Any other disease which is not expected to be relapsed without external stimulate
  • Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally relapsed cancer that has been cured after treatment (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
  • Received corticosteroid therapy at a dose ≥ 10 mg prednisone per day or any other systemic immunosuppressive therapy within 14 days prior to enrollment.
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  • Patient with uncontrolled diabetes, or abnormal potassium, sodium or corrected calcium levels (≥ grade 1) after receiving standard treatment, or ≥ grade 3 hypoalbuminemia within 14 days prior to enrollment
  • Patient with a history of interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, hypertension, etc.
  • Evidence of severe chronic or active infections (including tuberculosis infection) requiring systemic antibiotics, antibacterial or antiviral therapy within 14 days prior to enrollment
  • Patient with a history of HIV infection
  • Evidence of contraindications of immunotherapy or radiotherapy
  • Patient with untreated chronic hepatitis B or HBV-DNA≥ 500 IU/mL, or active hepatitis C.
  • Note: Patients with inactive infection of hepatitis B surface antigen (HBsAg), stable hepatitis B after treatment (HBV DNA < 500 IU/mL）and cured hepatitis C could be included.
  • Have undergone any operation requiring general anesthesia within 28 days prior to enrollment
  • Previous allogeneic stem cell transplantation or organ transplantation
  • Patient with any of the following cardiovascular risk factors: Cardiogenic chest pain within 28 days prior to enrollment, which is defined as moderate pain that limits instrumental activities of daily life; Symptomatic pulmonary embolism within 28 days prior to enrollment; Acute myocardial infarction within 6 months prior to enrollment; Grade III or IV disease according to the New York Heart Association within 6 months prior to enrollment;≥ Grade 2 ventricular arrhythmias within 6 months prior to enrollment or the first administration; With a history of cerebrovascular accident within 6 months prior to enrollment or the first administration
  • Grade 2 peripheral nerve disease according to NCI-CTCAE V5.0
  • Underlying medical conditions (including abnormal laboratory test values) that: affect drug administration; affect the interpretation of toxicity or AE; lead to poor compliance; alcohol or drug abuse or dependence
  • Participate in another interventional clinical study at the same time

Trial locations and contacts

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

China2 sites, 2 recruiting

  • Xinqiao Hospital of Chongqing

    Chongqing, Chongqing Municipality, 400000

    Sun Jianguo, 023-68774490, yanmaizhixiang@sina.cn

    023774490 ext. 0086

    Recruiting

  • the second affiliated hospital of Army medical university

    Chongqing, Chongqing Municipality, 40037

    jianguo sun, Phd, 023-68774490, sunjg09@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: Antitumor Activity of Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma: A Single-arm, Multicenter Study

The aim of the study was to determine the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma

Read the detailed description

Chemotherapy has been widely used for the treatment of relapsed or metastatic nasopharyngeal carcinoma. However, the long-term survival and quality of life of patients was still unsatisfactory. In this prospective, multicenter, single arm study, the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma is determined.

Being tested
Toripalimab
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • ToripalimabDrug

    Also called JS001

    Toripalimab: 240mg, iv. Q3W for 1 year or until disease progression/intolerable toxicity

    Radiotherapy:

    Newly diagnosed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 70 Gy, pGTVnd 99Gy, pCTV1, 60 Gy, pCTV2, 54 Gy, 33 times, completed in 7 weeks.

    Relapsed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 60Gy, pGTVnd 60Gy, 20-25 times, completed in 4-5 weeks.

    Newly diagnosed and relapsed patients: SBRT for oligometastatic lesions, pGTV 25-40 Gy, 3-5 times, completed in 1-2 weeks.

Study groups in NCT05147844
Study groupRoleWhat they receive
Toripalimab +RadiotherapyExperimentalNot described
Receives: Drug: Toripalimab

What is being measured

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

  1. 1-year progression-free survival rate according to RECIST v1.1

    To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by 1-year progression-free survival rate according to RECIST v1.1

    Measured: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. 1 year

Secondary outcomes (9)

  1. PFS according to RECIST v1.1

    To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by progression-free survival rate according to RECIST v1.1

    Measured: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

  2. OS

    To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by overall survival (OS)

    Measured: up to 5 years

  3. 2-year progression-free survival rate according to RECIST v1.1

    To evaluate the PFS rate at 2 years in the treatment arm

    Measured: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

  4. 2-year overall survival

    To evaluate the OS rate at 2 years in the treatment arm

    Measured: From date of randomization until death, loss to follow-up, or study termination by the Sponsor whichever occurs first.Up to 3.5 approximately years

  5. 1-year progression-free survival rate according to irRECIST

    To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by 1-year progression-free survival rate according to irRECIST

    Measured: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 1 approximately year

  6. ORR according to RECIST v1.1

    To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.

    Measured: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

  7. DCR according to RECIST v1.1

    To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1

    Measured: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years

  8. DoR according to RECIST v1.1

    To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1

    Measured: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

  9. AE(SAE)

    Incidence of serious adverse events(SAE) as assessed by CTCAE version 5.0

    Measured: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years

Timeline

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

  1. First posted7 Dec 2021
  2. Study start1 Mar 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Mar 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05147844
Sponsor's protocol ID
XQonc-017
Status last verified
Jul 2025
First submitted
23 Nov 2021
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab in people with Nasopharyngeal Carcinoma, run by Xinqiao Hospital of Chongqing at 2 sites 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 11 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year progression-free survival rate according to RECIST v1.1 (time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. 1 year). 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 NCT05147844.

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 14 Jul 2025.

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