Clinical trial NCT04895345: A Study of TQB2450 in Combination With Intensity-modulated Radiotherapy in Patients With Inoperable Locally Recurrent Nasopharyngeal Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: up to 48 weeks
Secondary outcomes:
measure: Disease control rate（DCR）
timeFrame: up to 48 weeks
measure: Duration of Response (DOR)
timeFrame: up to 48 weeks
measure: Progression-free survival (PFS)
timeFrame: up to 48 weeks
measure: 12-month progression-free survival rate
timeFrame: up to 48 weeks
measure: 12-month survival rate
timeFrame: up to 48 weeks
measure: 24-month survival rate
timeFrame: up to 96 weeks
measure: Local regional recurrence-free survival (LRRFs)
timeFrame: up to 48 weeks
measure: Distant metastasis-free survival (DMFS)
timeFrame: up to 48 weeks
measure: Overall survival (OS)
timeFrame: up to 96 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Hospital
state: Guangdong
Study officials:
References: