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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M NPC

A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M NPC (NCT04830267) is a Phase 2 interventional studying Nasopharyngeal Carcinoma, sponsored by Chongqing University Cancer Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Nasopharyngeal Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 39 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed Written willing to sign a consent form 2. Subjects must have signed and dated an IRB/IEC approved written willing to sign a consent form form in accordance with regulatory and institutional guidelines. 3. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations. 4. Target Population: Males and females ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. diagnosed by tissue sample (biopsy-confirmed) metastatic or recurrent nasopharyngeal carcinoma. 5. Subjects must have at least two lesions: At least one lesion must be safely amenable to irradiation. This can be a lesion that was previously irradiated as long as prior radiation was at least 6 months prior to projected first fraction of SBRT and as long as reirradiation dose constraints are being met. A separate, not-to-be-irradiated lesion measurable by CT or MRI per RECIST 1.1 criteria. 6. The peripheral blood EBV DNA copy number can be obtained. 7. Prior palliative or curative radiotherapy must be completed at least 14 days prior to randomization. 8. Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses \>10mg/day prednisone or equivalent) must be discontinued at least 14 days prior to Camrelizumab administration. 9. Screening laboratory values must meet the following criteria (using CTCAE v4.0) and should be obtained within 28 days prior to randomization: WBC ≥ 2 K/microliter Neutrophils ≥ 1.5 K/microliter platelet count at least 100 K/microliter blood count (hemoglobin) at least 9.0 g/deciliter Serum Creatinine ≤ 1.5 x ULN or creatinine clearance \> 40ml/min using the Cockcroft-Gault formula. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Signed Written Informed Consent 2. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. 3. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations. 4. Target Population: Males and females ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Histologically confirmed metastatic or recurrent nasopharyngeal carcinoma. 5. Subjects must have at least two lesions: At least one lesion must be safely amenable to irradiation. This can be a lesion that was previously irradiated as long as prior radiation was at least 6 months prior to projected first fraction of SBRT and as long as reirradiation dose constraints are being met. A separate, not-to-be-irradiated lesion measurable by CT or MRI per RECIST 1.1 criteria. 6. The peripheral blood EBV DNA copy number can be obtained. 7. Prior palliative or curative radiotherapy must be completed at least 14 days prior to randomization. 8. Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses \>10mg/day prednisone or equivalent) must be discontinued at least 14 days prior to Camrelizumab administration. 9. Screening laboratory values must meet the following criteria (using CTCAE v4.0) and should be obtained within 28 days prior to randomization: WBC ≥ 2 K/microliter Neutrophils ≥ 1.5 K/microliter Platelets ≥ 100 K/microliter Hemoglobin ≥ 9.0 g/deciliter Serum Creatinine ≤ 1.5 x ULN or creatinine clearance \> 40ml/min using the Cockcroft-Gault formula. Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL AST/ALT ≤ 3 x ULN Total bilirubin \<1.5 x ULN (except subjects with Gilbert Syndrome who can have total bilirubin \<3.0 mg/deciliter). Subjects must have a resting baseline O2 saturation by pulse oximetry of \>=92% at rest. 10. Reproductive Status: Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 28 days prior to randomization. Women must not be breastfeeding Women of childbearing potential must agree to follow instructions for method(s) of contraception from time of enrollment for the duration of treatment with Camrelizumab plus 5 half- lives plus 30 days for a total of 23 weeks post treatment completion. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving Camrelizumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception. Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements. However, they still must have a pregnancy test. Exclusion Criteria: 1. Target Disease Exceptions: Active brain metastases (untreated brain metastases or growth on imaging as defined below) or leptomeningeal disease are not allowed. Subjects with brain metastases are eligible if these have been treated and there is no MRI (or CT if MRI contraindicated) evidence of progression for at least 8 weeks after treatment for these metastases is complete and within 28 days prior to first study treatment. 2. Medical History and Concurrent Diseases: Any medical disorder that, in the opinion of the investigator, might increase the risk associated with study participation or interferes with the interpretation of study results. Prior active malignancy within the previous 3 years except for locally curable cancers such as basal or squamous skin cancer, superficial bladder, low risk prostate cancer, breast, or cervix cancer. If other prior malignancy was active within prior 3 years, enrollment requires approval of a principal investigator. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration should be excluded. Inhaled or topical steroids and adrenal replacement doses \>10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 3. Physical and Laboratory Test Findings: Positive test for hepatitis B virus surface antigen or hepatitis C virus ribonucleic acid indicating acute or chronic infection. Known history of testing positive for HIV or known AIDS. Any grade 4 laboratory abnormalities. Allergies and Adverse Drug Reaction History of allergy to Camrelizumab components History of severe hypersensitivity reaction to any monoclonal antibody. 4. Prohibited or Restricted Treatments: The following medications are prohibited during the study: Immunosuppressive agents (except to treat a drug-related adverse event). Systemic corticosteroids \> 10 mg daily prednisone equivalent save for exclusion outlined in the below paragraphs. Any concurrent chemotherapy, hormonal therapy, immunotherapy, or investigational agents for treatment of cancer.

Treatments Being Tested

DRUG

Camrelizumab

Camrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity.

RADIATION

Stereotactic body radiotherapy

Image guided, stereotactic body radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Camrelizumab).

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital
Wanzhou, Chongqing Municipality, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04830267), the sponsor (Chongqing University Cancer Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04830267 clinical trial studying?

Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04830267?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04830267?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04830267. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04830267. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.