Status:
NOT_YET_RECRUITING
GEP Combined With Radiotherapy in Non-locally Treatable Recurrent NPC
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Nasopharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research aims to assess both effectiveness and safety of combining R-GEP regimen comprising gemcitabine, recombinant human endostatin, and cerexinib with low- and high-dose radiotherapy in managi...
Detailed Description
Eligible patients will undergo screening before enrolling in this trial 。 The participants will receive R-GEP therapy according to specified dosing schedules over six cycles. Additionally administered...
Eligibility Criteria
Inclusion
- Patients aged ≥18 years;
- ECOG performance status 0-2;
- Pathological or clinical imaging diagnosis of recurrent nasopharyngeal carcinoma;
- With imaging assessable lesions (assessed by RECIST 1.1 criteria);
- Recurrent lesions are not eligible for curative local treatment (including but not limited to extensive invasion of recurrent lesions; recurrent lesions with obvious necrosis or ulceration, with bleeding risk; recurrent lesions extensively invading surrounding nerves/vessels or skin/muscle; obvious late radiation therapy complications after previous treatment: radiation-induced brain injury, posterior cranial nerve injury, dysphagia, severe myofibrosis; second or multiple courses of radiation therapy after recurrence or multiple recurrences);
- The following requirements must be met for the function of major organs:
- Hematological parameters tolerable to treatment: white blood cells ≥3.0×10\^9/L, neutrophils ≥1.5×10\^9/L, hemoglobin ≥9 g/dL, platelets ≥90×10\^9/L.
- Liver and kidney function: ALT, AST \<1.5 times the upper limit of normal (ULN), total bilirubin \<1.5×ULN, serum creatinine (Cr) ≤1.5×ULN; Echocardiographic assessment, left ventricular EF ≥50%;
- The patient has signed an informed consent form and is willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other research procedures.
- Voluntarily enroll in this study, sign an informed consent form, have good compliance and willingness to cooperate with follow-up.
Exclusion
- Subjects who cannot accept or tolerate chemotherapy or radiotherapy for various reasons;
- Subjects who can be cured by definitive radiotherapy or surgery;
- Subjects who have undergone major surgical procedures within the past 4 weeks or have not fully recovered from such procedures;
- Subjects who are currently participating in other drug clinical trials;
- Serious cardiac disease or discomfort, including but not limited to the following conditions:
- History of congestive heart failure or impaired systolic function (LVEF \<50%);
- Uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate \>100bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular conduction block (i.e., Mobitz Ⅱ second-degree atrioventricular conduction block or third-degree atrioventricular conduction block);
- Angina requiring anti-angina drug therapy;
- Clinically significant valvular heart disease;
- ECG showing a penetrating myocardial infarction;
- Uncontrolled hypertension (systolic blood pressure \>180mmHg and/or diastolic blood pressure \>100mmHg);
- Subjects who have a history of hypersensitivity to any component of the study drug;
- Any other situation in which the investigator deems the subject unsuitable to participate in the study.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06611826
Start Date
September 30 2024
End Date
December 30 2029
Last Update
September 25 2024
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