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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country25 target enrollmentJune 15, 2021

ConditionsNasopharyngeal Carcinoma

InterventionsTQB2450 Intensity modulated radiotherapy

DrugsTQB2450

Overview

Phase: Phase 2
Intervention: TQB2450
Conditions: Nasopharyngeal Carcinoma
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 25
Locations: 1
Primary Endpoint: Overall response rate (ORR)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 15, 2021

End Date

June 30, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understood and Signed an informed consent form;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months;
•Local recurrence of non-keratinizing nasopharyngeal carcinoma diagnosed by histopathology and/or cytology; Clinical stage: rT2-4N0-3M0 , RII-IVa phase (AJCC eighth edition);
•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;
•At least one measurable lesion (based on RECIST 1.1);
•Adequate laboratory indicators;
•No pregnant or breastfeeding women, and a negative pregnancy test.

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: TQB2450