Melanoma
Conditions
Brief summary
This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma
Interventions
DRUGSHR-1701
Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China
DRUGFamitinib
Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and ≤ 75 years, regardless of sex. * Histopathologically confirmed mucosal melanoma. * Focal, lymph node metastatic, or oligometastatic mucosal melanoma assessed as completely resectable by multidisciplinary team (surgery/ENT/gynecology/colorectal, radiotherapy, oncology, imaging/pathology, etc.). * ECOG Performance Status of 0 or 1. * Life expectancy ≥ 12 weeks.
Exclusion criteria
* Prior treatment with PD-1/PD-L1 antibodies or anti-angiogenic agents. * Ocular melanoma or melanoma of unknown primary site. * History of immunodeficiency, acquired or congenital immune deficiency diseases, or organ transplantation. * Pregnant or breastfeeding women. * Abnormal coagulation function (APTT \> 43 seconds or INR \> 1.5 × ULN), or history of bleeding tendency or bleeding events (e.g., gastrointestinal bleeding, gastric ulcer bleeding) within 3 months before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-Free Survival, EFS | From start of treatment to end of study, up to approximately 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | From start of treatment to end of study, up to approximately 36 months |
| Major Pathological Response (MPR) | Perioperative |
| Recurrence-Free Survival (RFS) | From surgery to end of study, up to ~36 months |
| Pathological Response Rate (pRR) | Perioperative |
| Objective Response Rate (ORR) | Perioperative |
| Adverse Events (AE) | From informed consent to 30 days after last dose |
| Serious Adverse Events (SAE) | From informed consent to 30 days after last dose |
Outcome results
None listed