NCT07517653Not yet recruitingPhase 2
Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma
A Multicenter, Phase II Clinical Trial of Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma (The ASPRIE-MM Study)
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 19 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Melanoma
- NCT number
- NCT07517653
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 1 Apr 2026 to the primary completion date, 30 Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with PD-1/PD-L1 antibodies or anti-angiogenic agents.
Other illness
- History of immunodeficiency, acquired or congenital immune deficiency diseases, or organ transplantation.
Lab values
- 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.
Other
- Ocular melanoma or melanoma of unknown primary site.
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.