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

NCT ID: NCT04895345

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2024-04-29

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2450+Intensity modulated radiotherapy

TQB2450 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.

Group Type: EXPERIMENTAL

TQB2450

Intervention Type: DRUG

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 radiotherapy

Intervention Type: RADIATION

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.

Interventions

TQB2450

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.

Intervention Type: DRUG

Intensity modulated radiotherapy

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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:

1. 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;

2. Has other malignant tumors within 3 years;

3. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;

4. Has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration;

5. Long-term unhealed wounds or fractures;

6. 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;

7. Has drug abuse history that unable to abstain from or mental disorders;

8. Has any severe and/or uncontrollable disease. 3.Tumor-related symptoms and treatment:

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1. Diagnosed local recurrence and received surgery, chemotherapy, radiotherapy or other anti-cancer therapies before first administration;

2. Has received NMPA approved Chinese patent medicines with anti-tumor indications;

3. Has received relevant immunotherapy drugs for PD-1, PD-L1, CTLA-4, etc.;

4. Uncontrollable pleural effusion, pericardial effusion or ascites that still needs to be drained repeatedly (as judged by the investigator); 4.Research and treatment related:

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1. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration;

2. Have severe hypersensitivity after using monoclonal antibodies;

3. 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;

4. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Hospital

Guangzhou, Guangdong, China

Countries

China

References

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 Oct 8:100846. doi: 10.1016/j.medj.2025.100846. Online ahead of print.

Reference Type: DERIVED

PMID: 41067232 (View on PubMed)

Other Identifiers

TQB2450-II-11

Identifier Type: -

Identifier Source: org_study_id