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Nasopharyngeal CarcinomaPhase 2NCT04895345

A Study of TQB2450 in Combination With Intensity-modulated Radiotherapy in Patients With Inoperable Locally Recurrent Nasopharyngeal Carcinoma

A Phase 2 study testing TQB2450 and Intensity modulated radiotherapy in people with Nasopharyngeal Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study to evaluate the efficacy and safety of TQB2450 injection combination with Intensity-modulated Radiotherapy in patients with inoperable locally recurrent nasopharyngeal carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
TQB2450 and Intensity modulated radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
15 Jun 2021to 29 Apr 2024
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

  • 1. Understood and Signed an informed consent form; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months; 3. Local recurrence of non-keratinizing nasopharyngeal carcinoma diagnosed by histopathology and/or cytology; Clinical stage: rT2-4N0-3M0 , RII-IVa phase (AJCC eighth edition); 4. The recurrence time is more than 12 months from the end of the first course of radiotherapy, without other systemic or local anti-tumor treatment; 5. At least one measurable lesion (based on RECIST 1.1); 6. Adequate laboratory indicators; 7. No pregnant or breastfeeding women, and a negative pregnancy test.

Who cannot join

  • 1. Operable patients with local recurrence, including rT2 (the tumor is confined to the surface of the parapharyngeal space, and the distance from the internal carotid artery > 0.5 cm) and rT3 (the tumor is confined to the bottom wall of the sphenoid sinus, and the distance from the internal carotid artery and cavernous sinus > 0.5 cm) ; 2.Combined diseases and medical history:
  • Accompanied by nasopharyngeal necrosis, radiation brain injury, severe neck fibrosis, or other ≥grade 3 radiation complications, the investigator has assessed that the risk is extremely high and not suitable for radiotherapy;
  • Has other malignant tumors within 3 years;
  • Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;
  • Has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration;
  • Long-term unhealed wounds or fractures;
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  • Arterial/venous thrombosis events occurred within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral; hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
  • Has drug abuse history that unable to abstain from or mental disorders;
  • Has any severe and/or uncontrollable disease. 3.Tumor-related symptoms and treatment:
  • <!-- -->
  • Diagnosed local recurrence and received surgery, chemotherapy, radiotherapy or other anti-cancer therapies before first administration;
  • Has received NMPA approved Chinese patent medicines with anti-tumor indications;
  • Has received relevant immunotherapy drugs for PD-1, PD-L1, CTLA-4, etc.;
  • Uncontrollable pleural effusion, pericardial effusion or ascites that still needs to be drained repeatedly (as judged by the investigator); 4.Research and treatment related:
  • <!-- -->
  • Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration;
  • Have severe hypersensitivity after using monoclonal antibodies;
  • Active autoimmune diseases that require systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the start of the study treatment;
  • Has immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy, and continue to use within 2 weeks of the first administration; 5.Has participated in other anti-tumor drug clinical trials within 4 weeks before the study; 6.According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Hospital

    Guangzhou, Guangdong, 510030

Other trials in China

About this study

Official title: An Open, Single-arm, Single-center, Phase II Clinical Trial of TQB2450 in Combination With Intensity-modulated Radiotherapy in Patients With Inoperable Locally Recurrent Nasopharyngeal Carcinoma

This is a study to evaluate the efficacy and safety of TQB2450 injection combination with Intensity-modulated Radiotherapy in patients with inoperable locally recurrent nasopharyngeal carcinoma.

Being tested
TQB2450, Intensity modulated radiotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • TQB2450Drug

    TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

  • Intensity modulated radiotherapyRadiation

    Intensity-modulated conformal radiotherapy (IMRT) is a kind of three dimensional conformal radiotherapy, which requires the dose intensity in the radiation field to be adjusted according to certain requirements.

Study groups in NCT04895345
Study groupRoleWhat they receive
TQB2450+Intensity modulated radiotherapyExperimentalTQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day；The total dose of radiotherapy should meet PTVnx: 60Gy/27Fr/2.22Gy, PTVnd: 60-64Gy/27Fr/2.22-2.37Gy, PTV1: 54Gy/27Fr/2.00Gy, once a day, 5 times/week.
Receives: Drug: TQB2450; Radiation: Intensity modulated radiotherapy

What is being measured

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

  1. Overall response rate (ORR)

    Percentage of participants achieving complete response (CR) and partial response (PR).

    Measured: up to 48 weeks

Secondary outcomes (9)

  1. Disease control rate（DCR）

    Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

    Measured: up to 48 weeks

  2. Duration of Response (DOR)

    The time when the participants first achieved complete or partial remission to disease progression.

    Measured: up to 48 weeks

  3. Progression-free survival (PFS)

    PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.

    Measured: up to 48 weeks

  4. 12-month progression-free survival rate

    12-month PFS defined as the time from first administration until the first documented progressive disease (PD) or death from any cause within 12 months.

    Measured: up to 48 weeks

  5. 12-month survival rate

    12-month survival rate defined as the time from first administration to death from any cause within 12 months.

    Measured: up to 48 weeks

  6. 24-month survival rate

    24-month survival rate defined as the time from first administration to death from any cause within 24 months.

    Measured: up to 96 weeks

  7. Local regional recurrence-free survival (LRRFs)

    The time interval between the patient's first medication and the appearance of local imaging progress.

    Measured: up to 48 weeks

  8. Distant metastasis-free survival (DMFS)

    The time interval between the patient's first medication and the appearance of distant metastasis imaging progression or death.

    Measured: up to 48 weeks

  9. Overall survival (OS)

    OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

    Measured: up to 96 weeks

Timeline

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

  1. First posted20 May 2021
  2. Study start15 Jun 2021
  3. Primary completion29 Apr 2024
  4. Study completion29 Apr 2024

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895345
Sponsor's protocol ID
TQB2450-II-11
Status last verified
Sep 2024
First submitted
17 May 2021
Last updated
26 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xia TL, Huang W, Liu YP, Feng ZK, Chen SY, Ding X, Peng L, Wu WB, Yu D, Yang AQ, Li X, Tang Y, He X, Hua YJ, You R, Chen MY. TQB2450 plus intensity-modulated radiotherapy in recurrent nasopharyngeal carcinoma: An open-label, single-arm, phase II trial. Med. 2025 Nov 14;6(11):100846. doi: 10.1016/j.medj.2025.100846. Epub 2025 Oct 8.

    PubMed 41067232

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQB2450 and Intensity modulated radiotherapy in people with Nasopharyngeal Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. 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 1 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: finished, as of the sponsor's last update on 26 Sep 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall response rate (ORR) (time frame: up to 48 weeks). 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 NCT04895345, which also lists 1 linked publication.

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 26 Sep 2024.

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