Status:
UNKNOWN
PD-1 Blockade and Bevacizumab Replace Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
The First Affiliated Hospital of Nanchang University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
At present, the treatment regimen of locally advanced nasopharyngeal carcinoma still needs to be further improved, and the focus of improvement lies in "replacing cisplatin with high-efficiency and lo...
Detailed Description
We plan to use PD-1 inhibitor combined with bevacizumab to replace cisplatin (induction + concurrent ± adjuvant) in patients with locally advanced nasopharyngeal carcinoma. Considering the safety of t...
Eligibility Criteria
Inclusion
- Voluntary participation with Written informed consent.
- Age ≥ 18 years and ≤ 65 years.
- Histologically confirmed with Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type).
- Original clinical staged as III-IVa (according to the 8th AJCC edition).
- Stage III patients should meet the criteria of EBV DNA≥4000 cps/ml.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Patients must have adequate organ function:
- White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) .
- Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value.
- INR, APTT≤1.5 x ULN.
Exclusion
- Subjects with recurrent or metastatic nasopharyngeal carcinoma.
- Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
- Prior therapy with systemic therapy for nasopharyngeal carcinoma.
- Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies.
- Prior exposure to antiangiogenic agents.
- Tumor invasion to the intracranial with clinical symptoms accompanied by cerebral edema, requiring hormone therapy.
- Any grade ≥2 bleeding event (according to CTCAE 5.0) occurred within 4 weeks prior to enrollment.
- Subjects with an active, known or suspected autoimmune disease.
- Subjects with clinically significant cardiovascular and cerebrovascular diseases.
- Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
- Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
- Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose.
- Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
- Seropositivity for human immunodeficiency virus (HIV).
- Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
Key Trial Info
Start Date :
April 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05341193
Start Date
April 30 2022
End Date
December 30 2025
Last Update
April 22 2022
Active Locations (1)
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1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060