Status:
NOT_YET_RECRUITING
Envafolimab Combined With Recombinant Human Endostatin and First-line Chemotherapy Treat of Advanced Mucosal Melanoma
Lead Sponsor:
Fudan University
Conditions:
Advanced Mucosal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II, open, single-center study to explore the efficacy and safety of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin in the treatment of mucosal melan...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old, regardless of gender.
- Histology and pathology confirmed advanced mucosal melanoma.
- Gene mutation state is not limited, except BRAFV600 mutation.
- Has not received first-line treatment for advanced melanoma, and temozolomide and cisplatin have been used in the adjuvant therapy phase, except that the adjuvant therapy phase has been over 6 months or more.
- Eastern Cancer Cooperation Group (ECOG) physical condition score (PS) 0-1.
- The estimated survival time is more than 3 months.
- Within 7 days before screening (including 7 days), the laboratory data were required as follows: neutrophil count ≥ 1.5 × 109 shock L, platelet count ≥ 90 × 109 shock L, hemoglobin ≥ 90g/L (no blood transfusion within 14 days), serum total bilirubin ≤ 1.25x normal upper limit (ULN), ALT and AST ≤ 2.5xULN (patients with liver metastasis ≤ 5xULN); serum creatinine ≤ 1.25xULN.
- Have at least one measurable focus (RECIST1.1 standard).
- Subjects (or their legal representatives / guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.
Exclusion
- Patients who have previously used PD-L1 inhibitors, except those who progressed 1 year after the end of adjuvant therapy of PD-L1 monoclonal antibody;
- Allergic to Envafolimab or recombinant human endostatin and experimental chemotherapeutic drugs;
- Received any experimental drugs or antineoplastic drugs within 4 weeks before entering the group;
- There is a risk of bleeding, bleeding events of clinical significance or other taboos in the use of antivascular drugs;
- There is a history of other tumors in the past five years, except for cured cervical cancer or skin basal cell carcinoma;
- There are tumor emergencies that require immediate radiotherapy, such as symptomatic brain or meningeal metastasis, bone-related events, etc;
- Pregnant or lactating women; Fertile women who do not use adequate contraception;
- Alcohol or drug addiction;
- Patients with active, or history of autoimmune diseases that may recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or patients at high risk (such as immunosuppressive therapy required for organ transplants). Except for autoimmune hypothyroidism that requires only hormone replacement therapy or skin diseases that do not require systemic treatment;
- Patients who need to receive systemic corticosteroids (dose equivalent to \> 10mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment or during the study. The use of topical or inhaled corticosteroids, or short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune and infrequent allergic diseases;
- Important organ failure or other serious diseases, including interstitial pneumonia, clinically related coronary artery disease, cardiovascular disease or myocardial infarction, congestive heart failure, unstable angina pectoris, symptomatic pericardial effusion or unstable arrhythmia within 6 months before admission;
- A history of human immunodeficiency virus infection, or other acquired, congenital immunodeficiency diseases, or a history of organ transplant or stem cell transplantation;
- Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, stable hepatitis B (DNA titer ≤ 103copies / ml) and cured hepatitis C patients (HCVRNA negative) can be enrolled in the group;
- A history of severe neurological or psychiatric illness; severe infection; active disseminated intravascular coagulation or other concomitant diseases that, in the opinion of the researchers, seriously endanger the safety of patients or affect the completion of the study.
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 18 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06041724
Start Date
September 18 2023
End Date
March 18 2026
Last Update
September 18 2023
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