Triple threat: new combo targets nasopharyngeal cancer spread
NCT ID NCT05524168
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing whether combining targeted radiation (SBRT) with an immunotherapy drug (camrelizumab) and standard chemotherapy can help control nasopharyngeal cancer that has spread to a few other parts of the body. The study involves 41 participants who have not had prior treatment for their metastatic disease. The main goal is to see how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Camrelizumab (PD-1 antibody), gemcitabine, cisplatin, and SBRT (radiation)
- What this could lead to
- If successful, this combination could offer a new treatment option to control cancer spread and delay progression in patients with nasopharyngeal carcinoma that has spread to a few spots.
- What could go wrong
- This is a small, early-phase trial with only 41 participants and no comparison group. The treatment may cause significant side effects from chemotherapy, immunotherapy, and radiation, and may not improve survival.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 41 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 to 75 years
- Sex
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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 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: * Diagnosed as metastatic NPC with no more than 5 metastatic lesions; * Histopathological diagnosis of NPC; * ECOG 0-1 point; * Has not received prior systemic treatment, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; * No contraindications to immunotherapy and chemoradiotherapy; * Every metastatic lesions could receive SBRT safely; * Subject must have a measurable target lesion based on RECIST v1.1; * Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L; * Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN; * Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); * Take effective contraceptions during and three months after treatment; * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin; * Unexplained fever \> 38.5 ℃, except for tumor fever; * Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); * Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive; * Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway; * Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; Have known allergy to large molecule protein products or any compound of study therapy; * Pregnant or breastfeeding; * Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma; * Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial; * Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
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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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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a targeted drug outperform chemotherapy in Tough-to-Treat nasopharyngeal cancer?
- Can an experimental drug shrink advanced solid tumors?
- Can a targeted therapy replace harsh chemo in nasopharyngeal cancer?
- Could adding extra chemo before standard therapy beat nasopharyngeal cancer?
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