Status:
COMPLETED
A Study of TQB2450 in Combination With Intensity-modulated Radiotherapy in Patients With Inoperable Locally Recurrent Nasopharyngeal Carcinoma
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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;
- 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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- 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.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04895345
Start Date
June 15 2021
End Date
April 29 2024
Last Update
September 26 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Hospital
Guangzhou, Guangdong, China, 510030