OncoMatch/Clinical Trials/NCT06965231
Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial
Is NCT06965231 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Toripalimab combined with Endostar for melanoma of skin.
Treatment: Toripalimab combined with Endostar — 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 in patients with clinical stage II cutaneous or acral malignant melanoma. The study aims to answer: 1. Does this combination improve the 2-year recurrence-free survival (2y-RFS) compared to historical data? 2. Is the treatment safe and tolerable for patients? Participants will: 1. Receive 2 cycles of toripalimab before surgery (neoadjuvant therapy). 2. Undergo surgical removal of the tumor. 3. Post surgery, receive toripalimab every 2 weeks + Endostar (72-hour continuous infusion every 4 weeks) for up to 6 cycles (Endostar) or 11 cycles (toripalimab). 4. Be monitored for tumor recurrence, side effects, and survival for up to 2 years after treatment. This is a single-arm, multicenter study involving 58 patients across several hospitals in China. Results will help determine if this combination could become a new standard adjuvant therapy for stage II melanoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: BRAF any tested
Required: KIT any tested
Required: NRAS any tested
Disease stage
Required: Stage II
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Hemoglobin ≥90 g/L (no transfusion within 14 days); ANC ≥1.5×10^9/L; PLT ≥100×10^9/L
Kidney function
serum creatinine ≤1.5×ULN, creatinine clearance >50 μmol/L; urinalysis proteinuria <++ or 24-hour urinary protein ≤1.0 g
Liver function
ALT and AST ≤2.5×ULN; total bilirubin ≤1.5×ULN
Cardiac function
LVEF ≥50% by Doppler ultrasound
Laboratory tests must meet the following criteria: 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; ALT and AST ≤2.5×ULN; total bilirubin ≤1.5×ULN; serum creatinine ≤1.5×ULN, creatinine clearance >50 μmol/L; APTT, INR, and PT ≤1.5×ULN; LVEF ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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