Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal M… (NCT07517653) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma
70 participantsStarted 2026-04-01
Plain-language summary
This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Event-Free Survival, EFS
Timeframe: From start of treatment to end of study, up to approximately 36 months