MelanomaPhase 2NCT07517653
Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma
A Phase 2 study testing SHR-1701 and Famitinib in people with Melanoma, run by Shanghai Zhongshan Hospital.
Trial summary
This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- SHR-1701 and Famitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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)
This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma
- Conditions
- Melanoma
- Being tested
- SHR-1701, Famitinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701Drug
Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China
FamitinibDrug
Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701 + Famitinib | Experimental | Not described Receives: Drug: SHR-1701; Drug: Famitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival, EFS
Measured: From start of treatment to end of study, up to approximately 36 months
Secondary outcomes (7)
Overall Survival (OS)
Measured: From start of treatment to end of study, up to approximately 36 months
Major Pathological Response (MPR)
Measured: Perioperative
Recurrence-Free Survival (RFS)
Measured: From surgery to end of study, up to ~36 months
Pathological Response Rate (pRR)
Measured: Perioperative
Objective Response Rate (ORR)
Measured: Perioperative
Adverse Events (AE)
Measured: From informed consent to 30 days after last dose
Serious Adverse Events (SAE)
Measured: From informed consent to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517653
- Sponsor's protocol ID
- B2026-002
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07517653
- Acronym / sponsor ID
- B2026-002
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1701 + Famitinib | Experimental | Drug: SHR-1701, Drug: Famitinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1701Specifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China | Drug | SHR-1701 + Famitinib |
| FamitinibSpecifically targets mucosal melanoma, which accounts for 22.6% of melanoma cases in China | Drug | SHR-1701 + Famitinib |
Primary outcome
Event-Free Survival, EFS
Time frame: From start of treatment to end of study, up to approximately 36 months
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1701 and Famitinib in people with Melanoma, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival, EFS (time frame: From start of treatment to end of study, up to approximately 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.