A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (NCT05924256) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
China88 participantsStarted 2023-07-26
Plain-language summary
This is a single-center, open-label, phase 2 study to evaluate the efficacy and safety of target therapy for patients with relapsed/metastastic salivary gland carcinoma based on molecular typing.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients volunteered to participate in this study and signed informed consent;
. Aged ≥ 18 but ≤ 75 years, male or female;
. Histologically confirmed to be locally advanced or metastatic salivary gland carcinoma;
. Arm1: salivary gland carcinoma patients with HER-2 overexpression ； Arm 2: salivary gland carcinoma patients with AR-positive; Arm 3: salivary gland carcinoma patients without HER-2 alteration or AR-positive; Arm 4: salivary gland carcinoma patients with low HER-2 expression;
. At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter of swollen lymph node should be ≥ 15 mm; according to RECIST vl.1 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress);
. ECOG Perfomance Status: 0\~1;
. Estimated survival time ≥ 12 weeks;
. The main organs function are normal, and meet the following requirements (within 7 days before the start of study treatment):
Exclusion criteria
. Have other active malignancies within 5 years or at the same time. Localized tumors that have been cured, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, can be enrolled.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ORR
Timeframe: at the end of every 2 cycles(for arm1, arm3 and arm4, each cycle is 21 days, for arm2, each cycle is 28 days)
. Other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, etc.) were used within 28 days prior to the first use of the study drug. if the last dose of anti-tumor drug had been stopped ≥ 5 half-life can be allowed.
. There are clinical symptoms or diseases of the heart that are not well controlled, such as:
. Patients with high blood pressure who cannot be reduced to normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (average of BP based on ≥2 measurements), allowing the use of antihypertensive treatment to achieve the above parameters.
. A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction) (Only apply for Arm 2 patients);
. Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions, and fecal occult blood (++); (2) those with a history of melena and hematemesis within 3 months;
. Abnormal coagulation function (INR\>1.5×ULN,activated partial thromboplastin time\>1.5×ULN), with bleeding tendency.