Resectable Mucosal MelanomaPhase 2NCT07336979
Paclitaxel Polymersomes + Carboplatin + Adebelimab: Neoadjuvant Phase Ⅱ Single-Arm Study for Resectable Mucosal Melanoma
A Phase 2 study testing Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab and Radical Surgery in people with Resectable Mucosal Melanoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the pathological response rate of neoadjuvant therapy with paclitaxel polymersomes for injection combined with carboplatin and adebrelimab in patients with resectable mucosal melanoma.Subjects will receive the combination therapy of paclitaxel polymersomes for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Mucosal Melanoma
- What is being tested?
- Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab and Radical Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2025to 20 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Histopathologically confirmed resectable mucosal melanoma.
- Subjects must provide 5 formalin-fixed paraffin-embedded (FFPE) tissue sections collected before treatment, or be willing to undergo needle biopsy for pathological tissue acquisition to facilitate pathological assessment.
- ECOG (Performance Status, PS) score of 0-1.
- No prior treatment with immune checkpoint inhibitors such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies.
- No prior treatment with taxane-based drugs.
Show all 11Show fewer
- Presence of measurable lesions (per RECIST 1.1 criteria).
- No history of immunosuppressant use within 6 months prior to enrollment.
- Hematological and biochemical test results meeting the following criteria:
- Neutrophil count ≥ 1,500 × 10⁹/L; ii. Platelet count ≥ 100 × 10⁹/L; iii. Hemoglobin > 9.0 g/dL; iv. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min; v. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 3 × ULN; vi. Total bilirubin ≤ 1.5 × ULN.
- Women of childbearing potential must have a negative serum or urine pregnancy test and agree to use an appropriate contraceptive method (barrier contraception or oral contraceptives).
Who cannot join
- Presence of distant metastatic lesions.
- Active autoimmune disease. Note: Patients with vitiligo, type 1 diabetes mellitus, or Hashimoto's thyroiditis with hypothyroidism who only require hormone replacement therapy may be enrolled if there is no evidence of significant disease recurrence.
- Need for systemic corticosteroid therapy (> 10 mg prednisolone [or equivalent]/daily) or other immunosuppressant use within 14 days after enrollment. Note: Inhaled or topical corticosteroids, or adrenal hormone replacement therapy (> 10 mg prednisolone [or equivalent]/daily) are acceptable for patients without obvious autoimmune diseases.
- Concurrent diagnosis of other malignant tumors requiring anti-tumor treatment. Note: Patients may be considered for enrollment if the other malignant tumor has achieved complete remission for 2 years or more and no additional anti-tumor treatment is required during the study period.
- Patients who are medically, psychologically, or physically unable to complete the study or understand the information provided in the patient brochure, as assessed by the investigator.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other drugs targeting T-cell costimulatory or immune regulatory pathways.
Show all 10Show fewer
- Prior chemotherapy with taxane-based drugs.
- Positive HIV test result or confirmed diagnosis of acquired immunodeficiency syndrome (AIDS).
- Known hypersensitivity to the study drugs.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
xizhiwen wen, +8602087343381, wenxz@sysucc.org.cn
About this study
Official title: A Single-Arm, Phase Ⅱ Exploratory Study of Neoadjuvant Therapy With Paclitaxel Polymersomes for Injection Combined With Carboplatin and Adebelimab in the Treatment of Resectable Mucosal Melanoma
The primary objective of this study is to evaluate the pathological response rate of neoadjuvant therapy with paclitaxel polymersomes for injection combined with carboplatin and adebrelimab in patients with resectable mucosal melanoma.Subjects will receive the combination therapy of paclitaxel polymersomes for injection, carboplatin and adebrelimab prior to surgery, with a treatment cycle of 3 weeks and a total of 3 cycles.After completing 3 cycles of treatment, subjects will undergo curative surgery. Pathologists will evaluate the surgically resected specimens to determine the status of pathological response, and immunohistochemical assays will be performed to assess the intensity of immune activation within the tumor microenvironment.
- Conditions
- Resectable Mucosal Melanoma
- Being tested
- Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab, Radical Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Polymersomes Combined with Carboplatin and AdebelimabDrug
Chemotherapeutic agents are administered on Day 1 of each cycle: paclitaxel polymersomes for injection is given first, followed by carboplatin.Adebelimab injection is administered on Day 2 of each cycle.Patients will receive a maximum of 3 cycles of neoadjuvant chemotherapy combined with immunotherapy before surgery.Patients who are evaluated as resectable 3 weeks after the last cycle of chemotherapy will undergo radical surgery.
Radical SurgeryProcedure or surgery
Chemotherapeutic agents are administered on Day 1 of each cycle: paclitaxel polymersomes for injection is given first, followed by carboplatin.Adebelimab injection is administered on Day 2 of each cycle.Patients will receive a maximum of 3 cycles of neoadjuvant chemotherapy combined with immunotherapy before surgery.Patients who are evaluated as resectable 3 weeks after the last cycle of chemotherapy will undergo radical surgery.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab | Experimental | Not described Receives: Drug: Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab; Procedure: Radical Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic response rate
The proportion of patients with less than 50% residual tumor cells in the surgically resected pathological specimens, including those who achieved pathological complete response (pCR), major pathological response (MPCR) and partial pathological response (pPR).
Measured: 8 weeks
Secondary outcomes (5)
overall response rate
The proportion of patients who achieve complete response (CR) or partial response (PR) evaluated according to the RECIST 1.1 criteria based on imaging examinations.
Measured: 8 weeks
Surgical Resection Rate
calculated as the number of patients who underwent scheduled surgical resection divided by the number of enrolled patients.
Measured: 8 weeks
Acute and Chronic Toxicities and Adverse Reactions
Measured: 8 weeks
relapse-free survival
Measured: 8 weeks
Assessment of Immune Activation Intensity in the Tumor Microenvironment
defined as the magnitude of changes in the proportions of CXCL13, CD4, CD8, CD19, and FOXP3-positive cells and the structural alterations of tertiary lymphoid organs (TLOs) in the tumor microenvironment before and after treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start20 Mar 2025
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Mucosal MelanomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xizhi wen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336979
- Sponsor's protocol ID
- B2024-799-01
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase Ⅱ Exploratory Study of Neoadjuvant Therapy With Paclitaxel Polymersomes for Injection Combined With Carboplatin and Adebelimab in the Treatment of Resectable Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT07336979
- Acronym / sponsor ID
- B2024-799-01
- Conditions
- Resectable Mucosal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 13 Jan 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.
The primary objective of this study is to evaluate the pathological response rate of neoadjuvant therapy with paclitaxel polymersomes for injection combined with carboplatin and adebrelimab in patients with resectable mucosal melanoma.Subjects will receive the combination therapy of paclitaxel polymersomes for injection, carboplatin and adebrelimab prior to surgery, with a treatment cycle of 3 weeks and a total of 3 cycles.After completing 3 cycles of treatment, subjects will undergo curative surgery. Pathologists will evaluate the surgically resected specimens to determine the status of pathological response, and immunohistochemical assays will be performed to assess the intensity of immune activation within the tumor microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab | Experimental | Drug: Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab, Procedure: Radical Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years old.
- Histopathologically confirmed resectable mucosal melanoma.
- Subjects must provide 5 formalin-fixed paraffin-embedded (FFPE) tissue sections collected before treatment, or be willing to undergo needle biopsy for pathological tissue acquisition to facilitate pathological assessment.
- ECOG (Performance Status, PS) score of 0-1.
- No prior treatment with immune checkpoint inhibitors such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies.
Key exclusion criteria (10 listed)
- Presence of distant metastatic lesions.
- Active autoimmune disease. Note: Patients with vitiligo, type 1 diabetes mellitus, or Hashimoto's thyroiditis with hypothyroidism who only require hormone replacement therapy may be enrolled if there is no evidence of significant disease recurrence.
- Need for systemic corticosteroid therapy (> 10 mg prednisolone [or equivalent]/daily) or other immunosuppressant use within 14 days after enrollment. Note: Inhaled or topical corticosteroids, or adrenal hormone replacement therapy (> 10 mg prednisolone [or equivalent]/daily) are acceptable for patients without obvious autoimmune diseases.
- Concurrent diagnosis of other malignant tumors requiring anti-tumor treatment. Note: Patients may be considered for enrollment if the other malignant tumor has achieved complete remission for 2 years or more and no additional anti-tumor treatment is required during the study period.
- Patients who are medically, psychologically, or physically unable to complete the study or understand the information provided in the patient brochure, as assessed by the investigator.
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 |
|---|---|---|
| Paclitaxel Polymersomes Combined with Carboplatin and AdebelimabChemotherapeutic agents are administered on Day 1 of each cycle: paclitaxel polymersomes for injection is given first, followed by carboplatin.Adebelimab injection is administered on Day 2 of each cycle.Patients will receive a maximum of 3 cycles of neoadjuvant chemotherapy combined with immunotherapy before surgery.Patients who are evaluated as resectable 3 weeks after the last cycle of chemotherapy will undergo radical surgery. | Drug | Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab |
| Radical SurgeryChemotherapeutic agents are administered on Day 1 of each cycle: paclitaxel polymersomes for injection is given first, followed by carboplatin.Adebelimab injection is administered on Day 2 of each cycle.Patients will receive a maximum of 3 cycles of neoadjuvant chemotherapy combined with immunotherapy before surgery.Patients who are evaluated as resectable 3 weeks after the last cycle of chemotherapy will undergo radical surgery. | Procedure or surgery | Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab |
Primary outcome
Pathologic response rate
Time frame: 8 weeks
The proportion of patients with less than 50% residual tumor cells in the surgically resected pathological specimens, including those who achieved pathological complete response (pCR), major pathological response (MPCR) and partial pathological response (pPR).
5 secondary outcomes
overall response rate
Time frame: 8 weeks
Surgical Resection Rate
Time frame: 8 weeks
Acute and Chronic Toxicities and Adverse Reactions
Time frame: 8 weeks
relapse-free survival
Time frame: 8 weeks
Assessment of Immune Activation Intensity in the Tumor Microenvironment
Time frame: 8 weeks
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 13 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Resectable Mucosal Melanoma
RecruitingPhase 2
Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery
Mucosal Melanoma, PD-L1 Positive
Not yet recruitingPhase 2
Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma
Melanoma
RecruitingPhase 2
Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)
Cutaneous Melanoma, Mucosal Melanoma
Not yet recruitingPhase 2
A Prospective, Single-Arm, Phase II Clinical Study of Neoadjuvant Therapy With Pucotenlimab, Lenvatinib, and Temozolomide for Resectable Head and Neck Mucosal Melanoma (PLT-NAT-HNMM-II)
Head and Neck Mucosal Melanomas
Active, not recruitingPhase 2
Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients With Resectable Head and Neck Mucosal Melanoma
Head and Neck Mucosal Melanomas
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab and Radical Surgery in people with Resectable Mucosal Melanoma, run by Sun Yat-sen University at 1 site in China.
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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact xizhiwen wen (+8602087343381, wenxz@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic response rate (time frame: 8 weeks). 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 13 Jan 2026.