New study tests bone tumor drug in chinese patients
NCT ID NCT04586660
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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36 people
The number who actually took part.
- Started
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Aug 2023
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035, China
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Harbin Meidical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
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National Taiwan University Hospital
Taipei, 10002, Taiwan
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Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510663, China
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Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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Tangdu Hospital of Air Force Medical University
Xi'an, Shaanxi, 710032, China
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The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
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The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
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The Third Affiliated Hospital Of Southern Medical University
Guangzhou, Guangdong, 510630, China
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