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New treatment option for Nasopharyngeal Carcinoma
Official title Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.
ClinicalTrials.gov ID: NCT06059261
What this study is testing
What is Envafolimab and recombinant human endostatin combined with chemoradiotherapy?
Envafolimab and recombinant human endostatin combined with chemoradiotherapy is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for nasopharyngeal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, prospective, single-arm, phase II clinical study, to evaluate the therapeutic efficacy and safety of envafolimab combined with chemoradiotherapy and recombinant human endostatin in patients with locally advanced nasopharyngeal carcinoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- ECOG score 0-1.
- Aged 18-65 years, male or non-pregnant female;
- Pathologically confirmed diagnosis of nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, WHO type II or III) without the...
- 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...
- MRI data of nasopharynx and neck before enrollment, and measurable lesions;
You likely can't join if
- Patients with recurrent nasopharyngeal carcinoma and distant metastasis.
- Pathology was keratinizing squamous cell carcinoma (WHO classification type I).
- Patients who have undergone radiotherapy or systemic chemotherapy;
- Pregnant or lactating women, in the reproductive period without effective contraceptive measures;
- HIV positive.
- Having had other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
See the full eligibility criteria
- ECOG score 0-1.
- Aged 18-65 years, male or non-pregnant female;
- 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.
- 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.)...
- MRI data of nasopharynx and neck before enrollment, and measurable lesions;
- 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.
- Agree to undergo EBV antibody and EBV-DNA quantitative testing before receiving treatment.
- Hematology: WBC ≥ 4000/μL, neutrophils ≥ 2.000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL;
- Liver function: ALT, AST \< 1.5 times the upper limit of normal (ULN), total bilirubin \< 1.5 × ULN;
- Renal function: serum creatinine \< 1.5 × ULN.
- 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;
- Patients with recurrent nasopharyngeal carcinoma and distant metastasis.
- Pathology was keratinizing squamous cell carcinoma (WHO classification type I).
- Patients who have undergone radiotherapy or systemic chemotherapy;
- Pregnant or lactating women, in the reproductive period without effective contraceptive measures;
- HIV positive.
- Having had other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
- Patients who have been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.);
- Patients need long-term use of immunosuppressive drug therapy, or systemic or local use of immunosuppressive doses of corticosteroids complications;
- Patients with immunodeficiency disease, history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism...
- Use of excessive doses of glucocorticoids within 4 weeks.
- Laboratory test values within 7 days before enrollment do not meet the relevant criteria;
- Patients with significantly low heart, liver, lung, kidney and bone marrow function.
- 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...
- 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;
- Severe, uncontrolled medical illness and infection.
- Concurrent use of other investigational drugs or ongoing other clinical trials;
- Refusing or unable to sign the informed consent form to participate in the trial.
- Personality or mental disorders, no civil capacity or limited civil capacity;
- Hepatitis B surface antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000cps/ml.
- Patients who tested positive for HCV antibody were included in the study only if they tested negative for HCV RNA by polymerase chain reaction.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.