GEP Combined With Radiotherapy in Non-locally Treatable Recurrent NPC

NCT06611826 | Not Yet Recruiting Phase 2

• 1 other identifier: IRB-2024-766（IIT）
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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 managing unresectable recurrent nasopharyngeal carcinoma.

Conditions

Nasopharynx Cancer

Outcome Measures

Primary Outcomes (1)

• 3 year OS rate

  3 year OS rate

  3 year

Secondary Outcomes (3)

• ORR

  3year

• DCR

  3year

• 3 year PFS rate

  3 year

Study Arms (1)

GEP

EXPERIMENTAL

Gemcitabine, recombinant human endostatin and carrilizumab combined with high-low dose radiotherapy

Drug: GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy

Interventions

GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy DRUG

The R-GEP regimen is as follows: Gemcitabine (G; 1.0 g/m2, d1, d8) in combination with recombinant human vascular endothelial growth factor (E; 150 mg, continuous intravenous infusion for 72 hours) and Carelizumab (P; 200 mg), administered every three weeks for a total of six cycles. During the 2nd-4th cycles, low-dose radiotherapy is administered to modulate the immune microenvironment (R: one course of radiotherapy per cycle: including booster fractions of 1 Gy\*3 times for the recurrent lesions, once a day, for three cycles). Approximately three weeks after the completion of the sixth cycle of GEP regimen (or the last cycle), high-dose fractionated radiotherapy (5-8 Gy\*5 times, once a day) is given to the recurrent lesions. Immune maintenance therapy continues until one year after treatment completion or disease progression.

Also known as: recombinant human endostatin

GEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Gemcitabine; Endostatins

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Central Study Contacts

Huang shuang

CONTACT

18258111085; hnhuangshuang525@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 25, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: September 25, 2024

Record last verified: 2024-09