Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial

ConditionsMelanoma of Skin Acral Melanoma Stage II Melanoma

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

Qualifiers

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

Treatments tested in this trial

Toripalimab combined with Endostar

Treatment groups

58 Participants

are divided into 1 treatment group

Locations

Cancer center, Shanghai 411 hospital, China RongTong Medical Healthcare Group Co.Ltd./411 Hospital, Shanghai University200081, ShanghaiShanghai Municipality, China

Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center200032, ShanghaiShanghai Municipality, China

Department of Oncology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine200336, ShanghaiShanghai Municipality, China

Department of Surgical Oncology, Fudan University Shanghai Cancer Center Minhang Branch Hospital200240, ShanghaiShanghai Municipality, China

Sponsors and collaborators

Fudan University

Lead sponsor

Shanghai Tong Ren Hospital

Collaborator

Shanghai 411 hospital

Collaborator

Source ClinicalTrials.gov