Not Yet RecruitingPhase 2

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

70 participantsStarted 2026-04-01

Plain-language summary

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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Event-Free Survival, EFS

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

Trial details

NCT IDNCT07517653

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-11-30

View on ClinicalTrials.gov More Melanoma trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.