New cocktail of drugs shows promise for Tough-to-Treat throat cancer
NCT ID NCT06059261
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing whether adding an immunotherapy drug (envafolimab) and a blood-vessel blocker (endostatin) to standard chemoradiotherapy can improve outcomes for 30 people with locally advanced nasopharyngeal carcinoma. The main goal is to see how many patients have a complete disappearance of their tumors after the initial treatment phase. The study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- envafolimab (an immunotherapy drug) combined with chemotherapy (cisplatin, gemcitabine) and recombinant human endostatin (a drug that blocks blood vessel growth to tumors)
- What this could lead to
- If successful, this combination could offer a more effective treatment option for people with advanced nasopharyngeal cancer, potentially improving tumor shrinkage and delaying progression.
- What could go wrong
- This is a small, early-phase (phase II) study with only 30 participants, so results may not apply to everyone. The combination of drugs may cause significant side effects, and it is not yet known if it works better than standard care.
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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
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 65 years
- 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: 1. ECOG score 0-1. 2. Aged 18-65 years, male or non-pregnant female; 3. Pathologically confirmed diagnosis of nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, WHO type II or III) without the need to detect MSI and dMMR status. 4. high-risk locally advanced stage III-IVA (8th AJCC/UICC staging), i.e., T4N+ or N2-3, or pretreatment EBV-DNA ≥4000 copies/ml, or lymph node extra-envelope invasion grade 3 (invasion of muscle skin, etc.), treatment-naive nasopharyngeal carcinoma patients. 5. MRI data of nasopharynx and neck before enrollment, and measurable lesions; 6. Agree to provide a previously stored tumor tissue specimen or biopsy to collect tumor lesion tissue and send it to the central laboratory for PD-L1 IHC testing. 7. Agree to undergo EBV antibody and EBV-DNA quantitative testing before receiving treatment. 8. Hematology: WBC ≥ 4000/μL, neutrophils ≥ 2.000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL; 9. Liver function: ALT, AST \< 1.5 times the upper limit of normal (ULN), total bilirubin \< 1.5 × ULN; 10. Renal function: serum creatinine \< 1.5 × ULN. 11. Patients have signed the informed consent form and are willing and able to comply with the study plan visits, treatment plan, laboratory tests and other study procedures; Exclusion Criteria: 1. Patients with recurrent nasopharyngeal carcinoma and distant metastasis. 2. Pathology was keratinizing squamous cell carcinoma (WHO classification type I). 3. Patients who have undergone radiotherapy or systemic chemotherapy; 4. Pregnant or lactating women, in the reproductive period without effective contraceptive measures; 5. HIV positive. 6. Having had other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ); 7. Patients who have been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.); 8. Patients need long-term use of immunosuppressive drug therapy, or systemic or local use of immunosuppressive doses of corticosteroids complications; 9. Patients with immunodeficiency disease, history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood, without any intervention after adulthood can be included; patients with asthma requiring bronchodilators for medical intervention can not be included; 10. Use of excessive doses of glucocorticoids within 4 weeks. 11. Laboratory test values within 7 days before enrollment do not meet the relevant criteria; 12. Patients with significantly low heart, liver, lung, kidney and bone marrow function. 13. Any other diseases or conditions are contraindications to recombinant human vascular endothelial inhibitors, chemoradiotherapy, immunotherapy (such as active phase of infection, within 6 months after myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy); 14. Any arterial thrombosis, embolism or ischemia within 6 months before inclusion for treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack; 15. Severe, uncontrolled medical illness and infection. 16. Concurrent use of other investigational drugs or ongoing other clinical trials; 17. Refusing or unable to sign the informed consent form to participate in the trial. 18. Personality or mental disorders, no civil capacity or limited civil capacity; 19. Hepatitis B surface antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000cps/ml. 20. Patients who tested positive for HCV antibody were included in the study only if they tested negative for HCV RNA by polymerase chain reaction.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chongqing University Cancer Hospital
RECRUITINGChongqing, Chongqing Municipality, 400030, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?
- 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?
- Smart T-Cell engager aims to outsmart tumors in first human test