Clinical trial · Interventional
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)
NCT07517653CI-TRIAL-00107580not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Famitinib | Drug | — | UNRESOLVED |
| SHR-1701 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1701 + Famitinib
- interventionNames
- Drug: SHR-1701
- Drug: Famitinib
Primary outcomes (1)
- measure
- Event-Free Survival, EFS
- timeFrame
- From start of treatment to end of study, up to approximately 36 months
Secondary outcomes (7)
- measure
- Overall Survival (OS)
- timeFrame
- From start of treatment to end of study, up to approximately 36 months
- measure
- Major Pathological Response (MPR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.