Platinum-Free Regimen in Nasopharyngeal Carcinoma

NCT07794488 | Not Yet Recruiting Phase 2

• 1 other identifier: ZJCC-NPC-202601
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasopharyngeal Cancinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  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.

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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.

Drug: Endostar (recombinant human endostatin injection)

Interventions

Endostar (recombinant human endostatin injection) DRUG

Low-dose radiotherapy

Also known as: Radiation

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Normal bone marrow function: white blood cell count \> 4×109/L, hemoglobin \> 90g/L, platelet count \> 100×109/L;

You may not qualify if:

• 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;
• Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
• Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment; history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved; Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia);
• Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
• Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible;
• Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2); 2) unstable angina; 3) myocardial infarction in past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention;
• Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility);
• Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
• Allergy to macromolecular protein preparations, or any component of camrelizumab;
• Active infection requiring systemic treatment;
• Receiving live vaccine within 30 days of the initial camrelizumab;
• History of organ transplantation;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Interventions

endostar protein; Endostatins; Radiation

Intervention Hierarchy (Ancestors)

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; Physical Phenomena

Study Officials

• Xiaozhong Chen, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caineng Cao, MD

CONTACT

+86-571-88128202; caocn@zjcc.org.cn

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 8, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)