Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Toripalimab combined with Endostar
Drug1. Neoadjuvant Phase: 2 doses of toripalimab (240 mg IV, Q2W) before surgery. 2. Surgery: Tumor resection within 2 weeks after the last neoadjuvant dose. 3. Adjuvant Phase: 1) Toripalimab: 240 mg IV every 2 weeks (up to 11 cycles); 2) Endostar: 210 mg (72-hour continuous IV infusion) every 4 weeks (up to 6 cycles).
Treatment groups
58 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year recurrence-free survival rate (2-year RFS rate)
Time frame
From enrollment to the end of the 2nd year of follow-upSecondary outcomes
1
1-year distant metastasis-free survival rate (1-year DMFS rate)
Time frame
From enrollment to the end of the 1st year2
Overall survival (OS)
Time frame
Through study completion, an average of 3 years3
1-year recurrence-free survival rate (1-year RFS rate)
Time frame
From enrollment to the end of the 1st year4
2-year distant metastasis-free survival rate (2-year DMFS rate)
Time frame
From enrollment to the end of the 2nd yearSponsors and contacts
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Source ClinicalTrials.gov