OncoMatch/Clinical Trials/NCT06965231
Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial
Is NCT06965231 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06965231 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require BRAF?
Yes, BRAF any tested is a required biomarker for enrollment.
Does this trial require KIT?
Yes, KIT any tested is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS any tested is a required biomarker for enrollment.
What disease stage is eligible?
Stage II is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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