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NCT Number: NCT07517653

Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-1701

Drug

Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China

Famitinib

Drug

Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China

Primary outcomes

  1. Event-Free Survival, EFS

    Time frame: From start of treatment to end of study, up to approximately 36 months

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From start of treatment to end of study, up to approximately 36 months

  2. Major Pathological Response (MPR)

    Time frame: Perioperative

  3. Recurrence-Free Survival (RFS)

    Time frame: From surgery to end of study, up to ~36 months

  4. Pathological Response Rate (pRR)

    Time frame: Perioperative

  5. Objective Response Rate (ORR)

    Time frame: Perioperative

  6. Adverse Events (AE)

    Time frame: From informed consent to 30 days after last dose

  7. Serious Adverse Events (SAE)

    Time frame: From informed consent to 30 days after last dose

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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