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

NCT04895345 | Completed Phase 2

• 1 other identifier: TQB2450-II-11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

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

  up to 48 weeks

Secondary Outcomes (9)

• Disease control rate（DCR）

  up to 48 weeks

• Duration of Response (DOR)

  up to 48 weeks

• Progression-free survival (PFS)

  up to 48 weeks

• 12-month progression-free survival rate

  up to 48 weeks

• 12-month survival rate

  up to 48 weeks

Study Arms (1)

TQB2450+Intensity modulated radiotherapy

EXPERIMENTAL

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.

Drug: TQB2450; Radiation: Intensity modulated radiotherapy

Interventions

TQB2450 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.

TQB2450+Intensity modulated radiotherapy

Intensity modulated radiotherapy 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.

TQB2450+Intensity modulated radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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;
• 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:
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• 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:
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Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Hospital

Guangzhou, Guangdong, 510030, China

Location

Related Publications (1)

• 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.

  PMID: 41067232 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: June 15, 2021
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)