Status:
RECRUITING
Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai 411 hospital
Conditions:
Melanoma of Skin
Acral Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II clinical trial to evaluate the efficacy and safety of perioperative toripalimab (anti-PD-1) combined with recombinant human endostatin (Endostar) as postoperative adjuvant therapy i...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, regardless of gender;
- ECOG performance status: 0-1;
- Patients with histologically or cytologically confirmed cutaneous or acral malignant melanoma, excluding mucosal and uveal melanoma;
- Patients with BRAF, CKIT, and NRAS gene test results;
- Treatment-naïve patients who have not received prior anti-tumor therapy;
- Clinical stage II (AJCC 8th edition, 2017);
- Laboratory tests must meet the following criteria:
- Hematology: Hemoglobin (Hb) ≥90 g/L (no transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelet count (PLT) ≥100×10\^9/L;
- Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance \>50 μmol/L;
- Coagulation: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤1.5×ULN;
- Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%;
- Female patients must agree to use contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during the study and for 6 months after study completion. A negative serum or urine pregnancy test within 7 days before enrollment is required, and patients must be non-lactating. Male patients must agree to use contraception during the study and for 6 months after study completion;
- Patients must voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance.
Exclusion
- History of allergic reactions to biological products;
- Patients with prior or concurrent malignancies within 5 years (except cured basal cell carcinoma of skin or carcinoma in situ of cervix);
- Any active autoimmune disease or history of autoimmune disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring bronchodilators for medical intervention). Exceptions include: vitiligo, psoriasis, alopecia not requiring systemic therapy, well-controlled type I diabetes, or hypothyroidism with normal thyroid function on replacement therapy;
- Requirement for immunosuppressive therapy using systemic or absorbable topical corticosteroids (equivalent to prednisone \>10mg/day) within 2 weeks prior to first dose;
- Any history or evidence of bleeding diathesis regardless of severity; grade ≥3 bleeding events per CTCAE v5.0 within 4 weeks prior to first dose; or presence of unhealed wounds, fractures, active gastrointestinal ulcers, ulcerative colitis, tumors with active bleeding, or other conditions deemed by investigators to potentially cause gastrointestinal hemorrhage or perforation;
- Patients with severe and/or uncontrolled comorbidities including:
- Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥90 mmHg);
- Unstable angina, myocardial infarction, ≥grade 2 congestive heart failure, or arrhythmias requiring treatment (including QTc ≥480ms) within 6 months prior to first dose;
- Active or uncontrolled severe infections (≥grade 2 per CTCAE);
- Clinically significant liver disease including viral hepatitis (active HBV infection with HBV DNA \>1×10³ copies/mL or \>500 IU/mL; HCV infection with HCV RNA \>1×10³ copies/mL or \>100 IU/mL), decompensated liver disease, or chronic hepatitis requiring antiviral therapy;
- HIV-positive status;
- Poorly controlled diabetes (fasting glucose ≥grade 2 per CTCAE);
- Urinalysis showing proteinuria ≥++ with 24-hour urinary protein \>1.0 g;
- Administration of live vaccines within 4 weeks prior to treatment or anticipated need during study;
- Other conditions deemed by investigators to potentially lead to premature study termination, including: severe comorbidities (including psychiatric disorders) requiring concomitant therapy, significant laboratory abnormalities, or social/family factors that may compromise patient safety or data/sample collection.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2029
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06965231
Start Date
January 1 2025
End Date
March 30 2029
Last Update
May 11 2025
Active Locations (4)
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1
Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
2
Cancer center, Shanghai 411 hospital, China RongTong Medical Healthcare Group Co.Ltd./411 Hospital, Shanghai University
Shanghai, Shanghai Municipality, China, 200081
3
Department of Surgical Oncology, Fudan University Shanghai Cancer Center Minhang Branch Hospital
Shanghai, Shanghai Municipality, China, 200240
4
Department of Oncology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200336