Platinum-Free Regimen in Nasopharyngeal Carcinoma

ConditionNasopharyngeal Cancinoma (NPC)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorZhejiang Cancer Hospital

About this trial

This study aimed to investigate the efficacy of a platinum-free neoadjuvant regimen (gemcitabine, camrelizumab, endostar, and low-dose radiotherapy) followed by a risk-adapted therapeutic strategy in patients with locally advanced nasopharyngeal carcinoma. Specifically, the risk-adapted approach was defined as follows: patients achieving a complete response after neoadjuvant therapy received radiotherapy alone; those with a partial response received radiotherapy plus concurrent endostar; and those with stable disease or progressive disease received radiotherapy plus concurrent cisplatin.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age at diagnosis between 18 and 70 years.

Histopathologically confirmed newly diagnosed nasopharyngeal carcinoma, classified as non-keratinizing carcinoma or keratinizing squamous cell carcinoma according to the World Health Organization (WHO) classification.

Diagnosed with stage II/III nasopharyngeal carcinoma (excluding T3N0) based on the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system, 9th edition. All subjects must undergo the following examinations prior to the initiation of first-line treatment to confirm clinical staging: complete medical history, physical examination, routine blood tests and biochemical assays, plasma Epstein-Barr virus (EBV) DNA titer and serological tests, nasopharyngoscopy, head and neck magnetic resonance imaging (MRI), and ¹⁸F-fluorodeoxyglucose positron emission tomography (¹⁸F-FDG PET).

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Disqualifiers

Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine transaminase and aspartate transaminase ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance rate ≥ 60 ml/min;

Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;

Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment.

Hepatitis B virus surface antigen (HBsAg) positive and HBV DNA > 1×10E3 copies/ml; anti-hepatitis C virus positive;

Trial design

Design model

Single group

Treatments tested in this trial

Endostar (recombinant human endostatin injection)
Drug
Low-dose radiotherapy

Treatment groups

145 Participants

are divided into 1 treatment group

Group A: Experimental ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Recurrence-free survival

Time frame

Time from enrollment to the first occurrence of disease recurrence (including distant metastasis or locoregional recurrence) or death from any cause, whichever occurs first, assessed up to 60 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: