Sebaceous Gland CarcinomaPhase 2NCT07740993
A Single-Arm Study of Sintilimab and Disitamab Vedotin for Locally Advanced Eyelid Sebaceous Gland Carcinoma
A Phase 2 study testing Sintilimab and disitamab vedotin in people with Sebaceous Gland Carcinoma, run by West China Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant therapy with Sintilimab combined with Disitamab Vedotin in patients with locally advanced, resectable or potentially resectable sebaceous gland carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sebaceous Gland Carcinoma
- What is being tested?
- Sintilimab and disitamab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age 18 to 85 years (inclusive), regardless of gender; 2.Pathologically confirmed sebaceous gland carcinoma of the eyelid meeting the following criteria: a) Locally advanced disease; b) Deemed resectable or potentially resectable based on ophthalmic evaluation; c) Willing to undergo surgical treatment; 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 4. Adequate organ and bone marrow functions defined as follows: a) Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 80 × 10^9/L; Hemoglobin ≥ 8 g/dL; b) Hepatic function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; c) Serum albumin ≥ 2.8 g/dL; d) Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCR) > 60 mL/min; e) Coagulation function: International Normalized Ratio (INR) ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 5. Volunteer to participate in the study, provide written informed consent, and be capable of complying with all protocol-specified visits and related procedures
Who cannot join
- Participants meeting any of the following criteria will be excluded: 1) History of other malignancies, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, and gastrointestinal intramucosal carcinoma with no recurrence within 5 years, or other malignancies deemed eligible by the investigator; 2) Any active autoimmune disease or history of autoimmune disease; 3) History of allergic diseases, severe drug allergies, or any component of the prescription (Note: severe allergy refers to those resulting in hospitalization); 4) Received any of the following treatments: a) Prior treatment with anti-PD-1, anti-PD-L1, or anti-HER2 therapies; b) Prior vaccination with anti-tumor vaccines; c) Use of any live vaccines against infectious diseases (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to the first dose or planned during the study period; d) Major surgery or severe trauma within 4 weeks prior to the first dose; 5) Concomitant severe medical conditions; 6) Known history of interstitial lung disease (ILD), non-infectious pneumonitis, or high suspicion of ILD, or subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity (subjects with a history of drug-induced or radiation-induced asymptomatic non-infectious pneumonitis are allowed to be enrolled), active tuberculosis, or a history of tuberculosis infection that remains uncontrolled after treatment; 7) Patients with hyperthyroidism and patients with organic thyroid diseases cannot be enrolled, patients with hypothyroidism on a stable dose of thyroid hormone replacement therapy can be enrolled, and patients with hypothyroidism controlled by thyroid hormone replacement therapy can be enrolled (whether it is controlled shall be confirmed by the investigator and/or the endocrinology department); 8) Active infection, or unexplained fever occurring during screening or within 48 hours prior to the first dose, or use of systemic antibiotics within 1 week prior to signing the informed consent form; 9) Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection of the assay), or a known history of positive human immunodeficiency virus (HIV) test, or known acquired immunodeficiency syndrome (AIDS); 10) Clear prior history of neurological or psychiatric disorders, such as epilepsy or dementia; 11) Clear history of drug abuse or history of alcohol abuse within 3 months; 12) Pregnant or lactating women, subjects (and their partners) who have reproductive plans, engage in unprotected sexual intercourse, or are unwilling to adopt appropriate contraceptive methods (such as condoms, intrauterine devices, or partner ligation) from the screening period up to 3 months after the end of the study; 13) Received any investigational drug within 4 weeks prior to the first use of the study drug, or concurrently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up phase of an interventional clinical study; 14) Other factors deemed by the investigator that may affect the study, leading to the inability to complete study treatment and follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xingchen Peng PhD contact
About this study
Official title: A Single-Arm, Prospective Clinical Study of Sintilimab Combined With Disitamab Vedotin as Neoadjuvant Therapy for Locally Advanced Eyelid Sebaceous Gland Carcinoma
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant therapy with Sintilimab combined with Disitamab Vedotin in patients with locally advanced, resectable or potentially resectable sebaceous gland carcinoma. The main questions it aims to answer are: What is the major pathological response (MPR) rate after the neoadjuvant therapy? What are the pathological complete response (pCR) rate, clinical objective response rate (ORR), disease control rate (DCR), safety profiles, and 1-year disease-free survival (DFS) of this regimen? Participants will:Receive neoadjuvant therapy consisting of Sintilimab (200 mg, IV, Day 1) and Disitamab Vedotin (2.5 mg/kg, IV, Day 1) every 3 weeks for a total of 2 cycles. Undergo radical surgery after the completion of the neoadjuvant treatment phase. Receive postoperative adjuvant therapy after surgery, which includes uniform Sintilimab monotherapy maintenance (200 mg, IV, Q3W) for up to 1 year, and may receive risk-stratified local interventions (such as local radiotherapy or repeat wide excision) depending on the pathological risk factors.
- Conditions
- Sebaceous Gland Carcinoma
- Being tested
- Sintilimab, disitamab vedotin
- Medical subject headings
- Adenocarcinoma, Sebaceous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab is administered at 200 mg intravenously on Day 1 of each 3-week cycle. In the neoadjuvant phase, it is given concurrently with Disitamab Vedotin for 2 cycles before radical surgery. In the adjuvant phase, post-surgery, it is administered as monotherapy maintenance for up to 1 year, or until intolerable toxicity or distant disease progression occurs.
disitamab vedotinDrug
Disitamab Vedotin is administered at 2.5 mg/kg intravenously on Day 1 of each 3-week cycle. It is given exclusively during the neoadjuvant phase for a total of 2 cycles concurrently with Sintilimab prior to radical surgery.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab Combined with Disitamab Vedotin | Experimental | Participants will receive neoadjuvant therapy consisting of intravenous sintilimab (200 mg) and disitamab vedotin (2.5 mg/kg, rounded to the nearest whole vial) on Day 1 of each 3-week cycle, for a total of 2 cycles. Following the neoadjuvant phase, patients will undergo radical surgical resection. Post-surgery, patients will receive adjuvant therapy comprising single-agent sintilimab (200 mg, intravenous, Q3W), continuing for 1 year or until unacceptable toxicity or disease progression occurs. Receives: Drug: Sintilimab; Drug: disitamab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathologic Response (MPR) Rate
Among participants who undergo surgery, major pathologic response (MPR) is defined according to immune-related pathologic response criteria (irPRC) as ≤10% residual viable tumor cells in the tumor bed (%RVT ≤10%), regardless of whether residual viable tumor cells are present in lymph nodes.
Measured: At the time of surgery, after completion of neoadjuvant treatment
Secondary outcomes (7)
Pathologic Complete Response (pCR) Rate
Among participants who undergo surgery, pathologic complete response (pCR) is defined according to immune-related pathologic response criteria (irPR) as no residual viable tumor cells in the tumor bed or resected lymph nodes (%RVT = 0).
Measured: At the time of surgery, after completion of neoadjuvant treatment
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR), as assessed according to RECIST version 1.1
Measured: From baseline to pre-operative tumor assessment following 2 cycles of neoadjuvant therapy (up to 9 weeks)
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants with a complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST version 1.1
Measured: From baseline to pre-operative tumor assessment following 2 cycles of neoadjuvant therapy (up to 9 weeks).
Adverse Events (AEs)
Adverse events (AEs) will be assessed according to CTCAE version 5.0, and all treatment-related adverse events will be reported to evaluate the safety of treatment.
Measured: From first dose through 30 days after the last dose of neoadjuvant treatment
Surgery Delay Rate
Surgery delay rate is defined as the proportion of participants whose interval between the completion of the 2nd cycle of neoadjuvant therapy and radical surgery exceeds 4 weeks (interval > 4 weeks) due to neoadjuvant therapy-related toxicities.
Measured: From completion of Cycle 2 of neoadjuvant therapy (each cycle is 21 days) to the date of radical surgery.
1-Year Disease-Free Survival (DFS) Rate
1-Year disease-free survival (DFS) rate is defined as the proportion of participants who remain alive and free of any tumor recurrence (local or regional) or distant metastasis at 1 year following radical surgery
Measured: From the date of radical surgery up to 1 year.
R0 Resection Rate
The proportion of participants who achieve R0 resection among those undergoing definitive surgery.
Measured: At the time of surgery, after completion of neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sebaceous Gland CarcinomaStudies of the same condition, open and under way.
- More trials run by West China 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng Peng, PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740993
- Sponsor's protocol ID
- 2026-1368
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective Clinical Study of Sintilimab Combined With Disitamab Vedotin as Neoadjuvant Therapy for Locally Advanced Eyelid Sebaceous Gland Carcinoma
- ClinicalTrials.gov ID
- NCT07740993
- Acronym / sponsor ID
- 2026-1368
- Conditions
- Sebaceous Gland Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 Aug 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 goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant therapy with Sintilimab combined with Disitamab Vedotin in patients with locally advanced, resectable or potentially resectable sebaceous gland carcinoma. The main questions it aims to answer are: What is the major pathological response (MPR) rate after the neoadjuvant therapy? What are the pathological complete response (pCR) rate, clinical objective response rate (ORR), disease control rate (DCR), safety profiles, and 1-year disease-free survival (DFS) of this regimen? Participants will:Receive neoadjuvant therapy consisting of Sintilimab (200 mg, IV, Day 1) and Disitamab Vedotin (2.5 mg/kg, IV, Day 1) every 3 weeks for a total of 2 cycles. Undergo radical surgery after the completion of the neoadjuvant treatment phase. Receive postoperative adjuvant therapy after surgery, which includes uniform Sintilimab monotherapy maintenance (200 mg, IV, Q3W) for up to 1 year, and may receive risk-stratified local interventions (such as local radiotherapy or repeat wide excision) depending on the pathological risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab Combined with Disitamab Vedotin | Experimental | Drug: Sintilimab, Drug: disitamab vedotinParticipants will receive neoadjuvant therapy consisting of intravenous sintilimab (200 mg) and disitamab vedotin (2.5 mg/kg, rounded to the nearest whole vial) on Day 1 of each 3-week cycle, for a total of 2 cycles. Following the neoadjuvant phase, patients will undergo radical surgical resection. Post-surgery, patients will receive adjuvant therapy comprising single-agent sintilimab (200 mg, intravenous, Q3W), continuing for 1 year or until unacceptable toxicity or disease progression occurs. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Age 18 to 85 years (inclusive), regardless of gender; 2.Pathologically confirmed sebaceous gland carcinoma of the eyelid meeting the following criteria: a) Locally advanced disease; b) Deemed resectable or potentially resectable based on ophthalmic evaluation; c) Willing to undergo surgical treatment; 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 4. Adequate organ and bone marrow functions defined as follows: a) Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 80 × 10^9/L; Hemoglobin ≥ 8 g/dL; b) Hepatic function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; c) Serum albumin ≥ 2.8 g/dL; d) Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCR) > 60 mL/min; e) Coagulation function: International Normalized Ratio (INR) ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 5. Volunteer to participate in the study, provide written informed consent, and be capable of complying with all protocol-specified visits and related procedures
Key exclusion criteria (1 listed)
- Participants meeting any of the following criteria will be excluded: 1) History of other malignancies, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, and gastrointestinal intramucosal carcinoma with no recurrence within 5 years, or other malignancies deemed eligible by the investigator; 2) Any active autoimmune disease or history of autoimmune disease; 3) History of allergic diseases, severe drug allergies, or any component of the prescription (Note: severe allergy refers to those resulting in hospitalization); 4) Received any of the following treatments: a) Prior treatment with anti-PD-1, anti-PD-L1, or anti-HER2 therapies; b) Prior vaccination with anti-tumor vaccines; c) Use of any live vaccines against infectious diseases (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to the first dose or planned during the study period; d) Major surgery or severe trauma within 4 weeks prior to the first dose; 5) Concomitant severe medical conditions; 6) Known history of interstitial lung disease (ILD), non-infectious pneumonitis, or high suspicion of ILD, or subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity (subjects with a history of drug-induced or radiation-induced asymptomatic non-infectious pneumonitis are allowed to be enrolled), active tuberculosis, or a history of tuberculosis infection that remains uncontrolled after treatment; 7) Patients with hyperthyroidism and patients with organic thyroid diseases cannot be enrolled, patients with hypothyroidism on a stable dose of thyroid hormone replacement therapy can be enrolled, and patients with hypothyroidism controlled by thyroid hormone replacement therapy can be enrolled (whether it is controlled shall be confirmed by the investigator and/or the endocrinology department); 8) Active infection, or unexplained fever occurring during screening or within 48 hours prior to the first dose, or use of systemic antibiotics within 1 week prior to signing the informed consent form; 9) Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection of the assay), or a known history of positive human immunodeficiency virus (HIV) test, or known acquired immunodeficiency syndrome (AIDS); 10) Clear prior history of neurological or psychiatric disorders, such as epilepsy or dementia; 11) Clear history of drug abuse or history of alcohol abuse within 3 months; 12) Pregnant or lactating women, subjects (and their partners) who have reproductive plans, engage in unprotected sexual intercourse, or are unwilling to adopt appropriate contraceptive methods (such as condoms, intrauterine devices, or partner ligation) from the screening period up to 3 months after the end of the study; 13) Received any investigational drug within 4 weeks prior to the first use of the study drug, or concurrently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up phase of an interventional clinical study; 14) Other factors deemed by the investigator that may affect the study, leading to the inability to complete study treatment and follow-up
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 |
|---|---|---|
| SintilimabSintilimab is administered at 200 mg intravenously on Day 1 of each 3-week cycle. In the neoadjuvant phase, it is given concurrently with Disitamab Vedotin for 2 cycles before radical surgery. In the adjuvant phase, post-surgery, it is administered as monotherapy maintenance for up to 1 year, or until intolerable toxicity or distant disease progression occurs. | Drug | Sintilimab Combined with Disitamab Vedotin |
| disitamab vedotinDisitamab Vedotin is administered at 2.5 mg/kg intravenously on Day 1 of each 3-week cycle. It is given exclusively during the neoadjuvant phase for a total of 2 cycles concurrently with Sintilimab prior to radical surgery. | Drug | Sintilimab Combined with Disitamab Vedotin |
Primary outcome
Major Pathologic Response (MPR) Rate
Time frame: At the time of surgery, after completion of neoadjuvant treatment
Among participants who undergo surgery, major pathologic response (MPR) is defined according to immune-related pathologic response criteria (irPRC) as ≤10% residual viable tumor cells in the tumor bed (%RVT ≤10%), regardless of whether residual viable tumor cells are present in lymph nodes.
7 secondary outcomes
Pathologic Complete Response (pCR) Rate
Time frame: At the time of surgery, after completion of neoadjuvant treatment
Objective Response Rate (ORR)
Time frame: From baseline to pre-operative tumor assessment following 2 cycles of neoadjuvant therapy (up to 9 weeks)
Disease Control Rate (DCR)
Time frame: From baseline to pre-operative tumor assessment following 2 cycles of neoadjuvant therapy (up to 9 weeks).
Adverse Events (AEs)
Time frame: From first dose through 30 days after the last dose of neoadjuvant treatment
Surgery Delay Rate
Time frame: From completion of Cycle 2 of neoadjuvant therapy (each cycle is 21 days) to the date of radical surgery.
1-Year Disease-Free Survival (DFS) Rate
Time frame: From the date of radical surgery up to 1 year.
R0 Resection Rate
Time frame: At the time of surgery, after completion of neoadjuvant treatment
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 3 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Xingchen Peng PhD contact
Xingchen Peng Peng, PhD principal investigator
West China Hospital
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 Sintilimab and disitamab vedotin in people with Sebaceous Gland Carcinoma, run by West China Hospital 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 1 inclusion and 1 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 3 Aug 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 Huaju yang PhD (+8613340239461, yhjyanghuaju@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathologic Response (MPR) Rate (time frame: At the time of surgery, after completion of neoadjuvant treatment). 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 3 Aug 2026.