Status:
RECRUITING
Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.
Lead Sponsor:
Chongqing University Cancer Hospital
Collaborating Sponsors:
Fujian Cancer Hospital
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a multicenter, prospective, single-arm, phase II clinical study, to evaluate the therapeutic efficacy and safety of envafolimab combined with chemoradiotherapy and recombinant human endostatin...
Detailed Description
This is a multicenter, prospective, single-arm phase II clinical study. Patients with high-risk locally advanced stage III-IVA (8th AJCC/UICC staging) primary nasopharyngeal carcinoma, i.e., T4N+ or N...
Eligibility Criteria
Inclusion
- 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.), treatment-naive nasopharyngeal carcinoma patients.
- 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;
Exclusion
- 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; 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;
- 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 infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
- 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.
Key Trial Info
Start Date :
August 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06059261
Start Date
August 4 2024
End Date
October 1 2027
Last Update
August 6 2024
Active Locations (1)
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1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030