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)

This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: SHR-1701; Drug: Famitinib

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1701 + Famitinib	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event-Free Survival, EFS	From start of treatment to end of study, up to approximately 36 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; famitinib; SHR-1701
• Other Study ID Numbers: B2026-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No