Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1701, Famitinib.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma
Interventions
- Drug SHR-1701
Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China - Drug Famitinib
Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China
Primary outcome measures
- Event-Free Survival, EFS [Time frame: From start of treatment to end of study, up to approximately 36 months]
Secondary outcome measures (7)
- Overall Survival (OS) [Time frame: From start of treatment to end of study, up to approximately 36 months]
- Major Pathological Response (MPR) [Time frame: Perioperative]
- Recurrence-Free Survival (RFS) [Time frame: From surgery to end of study, up to ~36 months]
- Pathological Response Rate (pRR) [Time frame: Perioperative]
- Objective Response Rate (ORR) [Time frame: Perioperative]
- Adverse Events (AE) [Time frame: From informed consent to 30 days after last dose]
- Serious Adverse Events (SAE) [Time frame: From informed consent to 30 days after last dose]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07517653 · B2026-002