Clinical trial · Interventional
GEP Combined With Radiotherapy in Non-locally Treatable Recurrent NPC
A Prospective, Single-arm Phase II Clinical Study of GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy in Non-locally Treatable Recurrent Nasopharyngeal Carcinoma
NCT06611826CI-TRIAL-00081024not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 managing unresectable recurrent nasopharyngeal carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharynx Cancer | Nasopharyngeal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GEP
- description
- Gemcitabine, recombinant human endostatin and carrilizumab combined with high-low dose radiotherapy
- interventionNames
- Drug: GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy
Primary outcomes (1)
- measure
- 3 year OS rate
- timeFrame
- 3 year
- description
- 3 year OS rate
Secondary outcomes (3)
- measure
- ORR
- timeFrame
- 3year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged ≥18 years; 2. ECOG performance status 0-2; 3. Pathological or clinical imaging diagnosis of recurrent nasopharyngeal carcinoma; 4. With imaging assessable lesions (assessed by RECIST 1.1 criteria); 5. 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); 6. 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%; 7. 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. 8. Voluntarily enroll in this study, sign an informed consent form, have good compliance and willingness to cooperate with follow-up. Exclusion Criteria: 1. Subjects who cannot accept or tolerate chemotherapy or radiotherapy for various reasons; 2. Subjects who can be cured by definitive radiotherapy or surgery; 3. Subjects who have undergone major surgical procedures within the past 4 weeks or have not fully recovered from such procedures; 4. Subjects who are currently participating in other drug clinical trials; 5. 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); 6. Subjects who have a history of hypersensitivity to any component of the study drug; 7. Any other situation in which the investigator deems the subject unsuitable to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.