A Phase 2 interventional study of abiraterone combined with dalpiciclib in Salivary Gland Carcinoma, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Phase 2, Interventional, and Treatment
This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of abiraterone combined with dalpiciclib in recurrent/metastatic salivary gland carcinoma patients with AR positive and Her-2 negative. The participants would receive abiraterone combined with dalpiciclib until termination criteria are met.
Salivary gland malignancy (SGM) accounts for 1%-5% of all head-and-neck malignancies, with an overall incidence of approximately 0.4-13.5 per 100 000 persons. The vast majority are epithelial neoplasms, while mesenchymal-origin tumors are relatively rare. SGM exhibits a broad spectrum of histological appearances and diverse biological behaviors. Currently, surgical resection and radiotherapy remain the mainstay of curative-intent therapy for SGM. Nevertheless, one distinct feature of salivary gland malignancy is the potential occurrence of "dedifferentiation" during tumor progression, accompanied by increased malignant potential. Once dedifferentiation develops, salivary gland malignancy is highly prone to recurrence and metastasis.
For recurrent and/or metastatic salivary gland malignancy, drug development has advanced slowly owing to its low incidence, leaving clinicians with limited therapeutic options. The optimal systemic treatment for recurrent/metastatic salivary gland carcinoma (R/M SGC) remains undefined. Clinically, combination chemotherapy, HER2-targeted inhibitors, and androgen-deprivation therapy (ADT) are among the available approaches; however, treatment responses vary, and high-level clinical trial evidence comparing different therapeutic strategies is lacking. Salivary gland malignancy comprises numerous pathological subtypes with substantial heterogeneity, and molecular profiles differ markedly across subtypes, which directly determines treatment response and prognosis.
Androgen receptor (AR) represents one of the key biomarkers for recurrent and/or metastatic salivary gland malignancy. Nevertheless, AR expression varies considerably across histological subtypes of salivary gland carcinoma (SGC): AR positivity reaches up to 98% in salivary duct carcinoma (SDC), 30% in adenocarcinoma, not otherwise specified (AC NOS), and as low as 15% and 5% in acinic cell carcinoma and mucoepidermoid carcinoma (MEC), respectively. Prospective phase II trials have investigated the efficacy of androgen-deprivation therapy (ADT) combined with bicalutamide (complete androgen blockade, CAB) in AR-positive SDC. That trial enrolled 36 pretreated patients with AR-positive SGC (94% SDC, 6% AC NOS) who received leuprorelin plus daily bicalutamide 80 mg for complete androgen blockade. The objective response rate (ORR) was 41.7% (95%CI: 25.5%-59.2%), median progression-free survival (mPFS) was 8.8 months (95%CI: 6.3-12.8 months), and median overall survival (mOS) was 30.5 months (95%CI: 16.8-not reached). Collectively, these findings are consistent with prior retrospective analyses evaluating ADT for R/M SGC. Boon E et al. reported a retrospective series of 35 patients with advanced/recurrent AR-positive SDC receiving first-line ADT, yielding a partial response (PR) rate of 18%, mPFS of 4 months (95%CI: 3-5 months), and mOS of 17 months (95%CI: 10-24 months). Consistent survival benefits were also observed in the adjuvant setting: a retrospective analysis by Van Boxtel et al. demonstrated significant improvements in overall survival (OS) and disease-free survival (DFS) among high-risk patients with AR-positive SDC treated with adjuvant ADT/complete androgen blockade (OS: HR = 0.064, 95%CI: 0.005-0.764, P = 0.030; DFS: HR = 0.138, 95%CI: 0.025-0.751, P = 0.022). Emerging evidence suggests biological parallels between salivary gland malignancy and prostate as well as breast cancer, which may provide novel therapeutic opportunities for SGC.
Combination regimens of CDK4/6 inhibitors plus endocrine therapy have achieved breakthroughs in hormone-dependent malignancies, particularly breast and prostate cancer. In breast cancer, such combinations constitute core therapeutic options for hormone-receptor-positive, HER2-negative disease, and are explicitly recommended in 2024 ASCO and CSCO guidelines. The MonarchE trial has firmly established the efficacy of abemaciclib combined with endocrine therapy in high-risk early-stage breast cancer. At a median follow-up of 54 months, the abemaciclib-containing group showed a 32% reduction in the risk of invasive cancer recurrence or death versus endocrine monotherapy (HR = 0.680, 95%CI 0.599-0.772), with absolute improvements of 7.6% in 5-year invasive-disease-free survival and 6.7% in distant-recurrence-free survival. Guidelines recommend 2 years of abemaciclib plus at least 5 years of endocrine therapy for node-positive patients at high recurrence risk. The phase III NATALEE trial of ribociclib plus endocrine therapy reported a 3-year invasive-disease-free survival rate of 90.4% in stage II-III hormone-receptor-positive, HER2-negative early breast cancer, representing a 3.3% absolute improvement over endocrine monotherapy (HR = 0.75, 95%CI 0.62-0.91, P = 0.003), alongside significant gains in distant-metastasis-free survival. In prostate cancer, exploration of CDK4/6 inhibitors combined with ADT lags behind breast cancer but has demonstrated clear synergistic potential. As an androgen-driven malignancy, prostate cancer exhibits AR-driven activation of the CDK4/6-cyclin D1 axis, furnishing the molecular rationale for this combination strategy. Early-phase clinical studies indicate that CDK4/6 inhibitors (e.g., abemaciclib, ribociclib) combined with ADT prolong progression-free survival and induce substantial tumor burden reduction in metastatic hormone-sensitive prostate cancer, potentially conferring extra benefit for patients with suboptimal responses to ADT alone. These data provide critical references for therapeutic exploration in AR-positive SGC.
This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of abiraterone combined with dalpiciclib in recurrent/metastatic salivary gland carcinoma patients with AR positive and Her-2 negative. The participants would receive abiraterone combined with dalpiciclib until termination criteria are met.
242 studies on the registry are indexed under Salivary Gland Neoplasms; 29 are open to participants now.
This study's planned enrollment of 36 is close to the median of 37 across 175 interventional studies indexed under Salivary Gland Neoplasms.
Browse Salivary Gland Neoplasms studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The dosing regimen for abiraterone combined with dalpiciclib is as follows: abiraterone is administered orally at 1 g once daily, in combination with prednisone 5 mg orally twice daily. The recommended dose of dalpiciclib is 150 mg once daily for 21 consecutive days, followed by a 7-day treatment break (3-on/1-off schedule), constituting a 28-day treatment cycle. Study subjects should take the medication at approximately the same time each day. Subjects will continue abiraterone plus dalpiciclib treatment until discontinuation criteria are met.
Drug: abiraterone combined with dalpiciclib
Drug pages: Abiraterone · Dalpiciclib
The dosing regimen for abiraterone combined with dalpiciclib isethionate is as follows: abiraterone is administered orally at 1 g once daily, in combination with prednisone 5 mg orally twice daily. The recommended dose of dalpiciclib isethionate is 150 mg once daily for 21 consecutive days, followed by a 7-day treatment break (3-on/1-off schedule), constituting a 28-day treatment cycle. Study subjects should take the medication at approximately the same time each day. Subjects will continue abiraterone plus dalpiciclib isethionate treatment until discontinuation criteria are met.
objective response rate
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time frame: 12 months
Progression Free Survival
PFS was defined as the time from enrollment to the first documented PD per RECIST 1.1, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD
Time frame: 12 months
overall survival
OS was defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Time frame: 12 months
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
Time frame: 12 months
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 39 non-industry phase 2 interventional studies under Salivary Gland Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 90. This study's planned 24 months is below that.
Counting every sponsor, half of 45 studies reached it within 59 months; a quarter within 33 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Abiraterone · Dalpiciclib
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →