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New study tests bone tumor drug in chinese patients

NCT ID NCT04586660

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 4 study tests the drug XGEVA (denosumab) in 36 Chinese adults and teens with giant cell tumor of bone, a rare but aggressive bone tumor. Participants receive injections every 4 weeks. The goal is to see if the drug shrinks tumors or helps make surgery easier. The study is active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Denosumab (XGEVA)
What this could lead to
If successful, this could confirm that denosumab helps shrink or control giant cell tumors of the bone in Chinese patients, offering a non-surgical option.
What could go wrong
This is a small, single-country study (36 participants) with no placebo group. Results may not apply to other populations, and long-term risks like jaw problems or low calcium levels are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

36 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Chinese male or female adults aged ≥ 18 years or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone \[eg, humerus with closed growth epiphyseal plate\]) ≥ 12 years of age. * Skeletally mature adolescents must weigh at least 45 kg. * Pathologically confirmed giant cell tumor of bone (GCTB) within 1 year before study enrollment (central pathology review). * Measurable evidence of active disease within 1 year before study enrollment. * Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) OR participants whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity. * Eastern Cooperative Oncology Group performance status (\[ECOG PS\] of ≤ 2). Exclusion Criteria: * Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma. * Known diagnosis of malignancy derived from non-musculoskeletal system within the past 5 years (participants with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted). * Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease. * Known or suspected current diagnosis of non GCTB giant cell-rich tumors. * Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw. * Active dental or jaw condition which requires oral surgery, including tooth extraction. * Non-healed wound after dental/oral surgery. * Planned invasive dental procedure for the course of the study. * Any planned treatment with intravenous (IV) or oral bisphosphonates during the study. * Currently receiving other GCTB-specific treatment (eg, radiation, chemotherapy, or embolization). * Current or previous XGEVA treatment * Concurrent bisphosphonate treatment * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. * Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 months after the last dose of XGEVA. * Female participants of childbearing potential unwilling to use 2 highly effective method of contraception or acceptable method of effective contraception during treatment and for an additional 5 months after the last dose of XGEVA. * Female participants of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test and/or urine pregnancy test. * Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 5 months after the last dose of XGEVA. * Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 5 months after the last dose of XGEVA. * Male participants unwilling to abstain from donating sperm during treatment and for an additional 5 months after the last dose of XGEVA. * Participant has known sensitivity to any of the products to be administered during dosing. * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge. * Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment. * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion. * Participant has any kind of disorder that compromises the ability of the participant to give written informed consent and/or to comply with study procedures.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100035, China

  • Harbin Meidical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510663, China

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tangdu Hospital of Air Force Medical University

    Xi'an, Shaanxi, 710032, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005, China

  • The Second Affiliated hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052, China

  • The Third Affiliated Hospital Of Southern Medical University

    Guangzhou, Guangdong, 510630, China

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