Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.
NCT ID: NCT06059261
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2024-08-04
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Envafolimab and recombinant human endostatin combined with chemoradiotherapy
Intervention Description: Induction envafolimab combined with recombinant endostatin and gemcitabine and cisplatin therapy for three cycles (every 3 weeks) followed by definitive radiotherapy with concurrent cisplatin chemotherapy. After 4 weeks of the completion of radiotherapy, adjuvant envafolimab therapy will begin every 3 weeks for 8 cycles or continue until progression or unacceptable toxicity.
Envafolimab and recombinant human endostatin combined with chemoradiotherapy
Induction treatment phase: Envafolimab administered by subcutaneous injection on day 1 every 3 weeks at 300 mg for 3 cycles, cisplatin administered by intravenous infusion on day 1 of each cycle at 80 mg/m2 every 3 weeks for 3 cycles, gemcitabine was administered by intravenous infusion on days 1 and 8 of each cycle at 1 g/m2 every 3 weeks for 3 cycles, recombinant human endostatin was administered on day 1 every 3 weeks at 210 mg for 3 cycles. Concurrent treatment phase: Cisplatin was administered by intravenous infusion on day 1 of each cycle at 100mg/m2 every 3 weeks for 2 cycles. Adjuvant treatment Phase: Envafolimab was administered on day 1 every 3 weeks at 300 mg for 8 cycles as a subcutaneous injection. Intensity-modulated radiotherapy: 69.96Gy/33fractions/7 weeks,5 fractions/week, 1 fraction/day.
Interventions
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Envafolimab and recombinant human endostatin combined with chemoradiotherapy
Induction treatment phase: Envafolimab administered by subcutaneous injection on day 1 every 3 weeks at 300 mg for 3 cycles, cisplatin administered by intravenous infusion on day 1 of each cycle at 80 mg/m2 every 3 weeks for 3 cycles, gemcitabine was administered by intravenous infusion on days 1 and 8 of each cycle at 1 g/m2 every 3 weeks for 3 cycles, recombinant human endostatin was administered on day 1 every 3 weeks at 210 mg for 3 cycles. Concurrent treatment phase: Cisplatin was administered by intravenous infusion on day 1 of each cycle at 100mg/m2 every 3 weeks for 2 cycles. Adjuvant treatment Phase: Envafolimab was administered on day 1 every 3 weeks at 300 mg for 8 cycles as a subcutaneous injection. Intensity-modulated radiotherapy: 69.96Gy/33fractions/7 weeks,5 fractions/week, 1 fraction/day.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Sun Yat-sen University
OTHER
Chongqing University Cancer Hospital
OTHER
Responsible Party
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JiangDong Sui
Deputy Director of Chongqing University Cancer Hospital
Principal Investigators
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Jiang D Sui, Ph.D, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chongqing University Cancer Hospital
Locations
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.
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Jiang XD, Dai P, Wu J, Song DA, Yu JM. Inhibitory effect of radiotherapy combined with weekly recombinant human endostatin on the human pulmonary adenocarcinoma A549 xenografts in nude mice. Lung Cancer. 2011 May;72(2):165-71. doi: 10.1016/j.lungcan.2010.09.003. Epub 2010 Oct 20.
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Guan Y, Li A, Xiao W, Liu S, Chen B, Lu T, Zhao C, Han F. The efficacy and safety of Endostar combined with chemoradiotherapy for patients with advanced, locally recurrent nasopharyngeal carcinoma. Oncotarget. 2015 Oct 20;6(32):33926-34. doi: 10.18632/oncotarget.5271.
Other Identifiers
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Lance
Identifier Type: -
Identifier Source: org_study_id
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