Neoadjuvant SHR-1701 Plus Famitinib With Response-guided... | NCT07517653

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

NCT07517653

Sponsor

Shanghai Zhongshan Hospital

Status

Not yet recruiting

Last Update Posted

Apr 8, 2026Actual

Enrollment

70Estimated

Phase

Phase 2

Conditions

Melanoma

Interventions

SHR-1701
Famitinib

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Nov 30, 2028Estimated

Completion Date

Dec 30, 2028Estimated

First Submitted Date

Mar 19, 2026

First Submission Date that Met QC Criteria

Mar 31, 2026

First Posted Date

Apr 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SHR-1701 + Famitinib	Experimental		Drug: SHR-1701 Drug: Famitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR-1701	Drug	Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China	SHR-1701 + Famitinib

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000723862	SHR-1701
C584390	famitinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided