ClinicalTrials.gg
Not yet recruitingNCT07794488Updated Aug 31, 2026

Platinum-Free Regimen in Nasopharyngeal Carcinoma

A Phase 2 interventional study of Endostar (recombinant human endostatin injection) in Nasopharyngeal Cancinoma (NPC), sponsored by Zhejiang Cancer Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Zhejiang Cancer Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
145
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Nasopharyngeal Cancinoma (NPC)
03

In context

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 282 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age at diagnosis between 18 and 70 years.
  2. Histopathologically confirmed newly diagnosed nasopharyngeal carcinoma, classified as non-keratinizing carcinoma or keratinizing squamous cell carcinoma according to the World Health Organization (WHO) classification.
  3. 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 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).
  4. (ECOG) performance status of 0 or 1.
  5. Normal bone marrow function: white blood cell count > 4×109/L, > 90g/L, count > 100×109/L;
  6. Normal values of thyroid function, amylase and lipase examination, pituitary function, inflammation and infection indicators, myocardial enzymes, and results. For patients older than 50 years with a smoking history, normal lung function are required. Patients with abnormal ECG and/or a history of vascular disease (but not meeting the exclusion criteria listed in the exclusion criteria 7) need further testing and require normal results of myocardial function and color Doppler ultrasound.
  7. Normal liver and kidney function: total ≤ 1.5 × (ULN); and aspartate transaminase ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; rate ≥ 60 ml/min;
  8. Patients must sign and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;
  9. Subjects with pregnancy ability must agree to use reliable measures from screening to 1 year after treatment.

Exclusion criteria

Exclusion Criteria:

  1. virus surface antigen (HBsAg) positive and HBV DNA > 1×10E3 copies/ml; anti- virus positive;
  2. Anti- (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
  3. 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 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);
  4. Previous interstitial lung disease or pneumonia requiring oral or intravenous therapy;
  5. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of therapy. Subjects who used inhaled or topical corticosteroids were eligible;
  6. Uncontrolled heart disease, for example: 1) heart failure ( level ≥ 2); 2) unstable angina; 3) myocardial infarction in past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention;
  7. Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility);
  8. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
  9. Allergy to macromolecular protein preparations, or any component of camrelizumab;
  10. Active infection requiring systemic treatment;
  11. Receiving within 30 days of the initial camrelizumab;
  12. History of organ transplantation;
  13. History of psychotropic disease, alcoholism or drug abuse; other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.

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Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
145 participants (estimated)

Study arms

  • Experimental
    Experimental Arm

    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

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What researchers measure

Primary outcomes

  1. 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.

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results will be shared with researchers who provide a methodologically sound proposal for indi- vidual participant data meta-analysis. Proposals should be directed to chenxz@zjcc.org.cn; to gain access, data requestors will need to sign a data access agreement. Data will be made available beginning 3 months and ending 5 years following article publication.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07794488
Responsible party
Chen Xiaozhong (MD, Zhejiang Cancer Hospital) — Principal investigator
First posted
Aug 31, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 30, 2030 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Aug 31, 2026

Study contacts

Caineng Cao, MD
Contact
caocn@zjcc.org.cn
+86-571-88128202
Xiaozhong Chen, MD
principal investigator · Zhejiang Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Endostar protein

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