Status:
UNKNOWN
The Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Nasopharyngeal Carcinoma
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study in to observe the effectiveness and safety of paclitaxel (albumin-bound type) combined with cisplatin, PD-1 inhibitor and IMRT in the treatment of locally advanced nasopharyn...
Detailed Description
This trial is a prospective, open, single-arm phase II clinical trial. The trial will enroll 40 patients with nasopharyngeal cancer stage III-IVA (UICC 8th edition). Subjects will receive paclitaxel (...
Eligibility Criteria
Inclusion
- Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma
- The stage is Ⅲ-ⅣA (UICC 8th edition)
- Initial treatment patients without anti-tumor therapy
- No history of other malignant tumors
- Male or female, aged 18\~70 years old
- Sufficient liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min
- Sufficient blood function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL
- No serious heart, lung, liver, kidney and other important organ dysfunction
- Karnofsky score ≥70 points
- No autoimmune diseases
- Sign informed consent
Exclusion
- Has performed anti-tumor treatment, including chemotherapy, radiotherapy, and surgery
- Discovery of distant metastases before treatment
- Receive live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study period
- Active, known or suspected autoimmune diseases
- Known history of primary immunodeficiency
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Women who are pregnant or breastfeeding
- Disagree to sign the informed consent form
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons
- Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research)
- Known allergic to possible chemotherapy drugs
- Accompanied by serious uncontrollable infections or medical diseases
- Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, unable to tolerate radiotherapy and chemotherapy
- Laboratory examination: total bilirubin\>upper limit of normal (ULN); AST and/or ALT\>1.5 times ULN and accompanied by alkaline phosphatase\>2.5 times ULN
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04769076
Start Date
March 1 2021
End Date
December 1 2025
Last Update
February 25 2021
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