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Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
RECRUITINGPhase 2Sponsored by Peking Union Medical College
Actively Recruiting
PhasePhase 2
SponsorPeking Union Medical College
Started2023-08-15
Est. completion2026-07-10
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06145308
Summary
Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and safety of precision therapy.
Eligibility
Age: 18 Years – 100 YearsHealthy volunteers accepted
Inclusion Criteria:
* Patients with histopathologic diagnosis of salivary gland carcinoma
* The tumor tissues were subjected to HER2/NTRK/AR/TROP-2 immunohistochemical staining.
* ECOG physical status 0 or 1 score in the 3 days before the first medication of the study treatment;
* Age 18 or older - no upper limit;
* Life expectancy is more than 3 months; ⑥Have at least one measurable lesion according to RECIST1.1 standards; ⑦Women of childbearing age must have a negative pregnancy test within 7 days before the first medication, and agree to receive the necessary contraceptive measures;
⑧The patient must have adequate liver, kidney, bone marrow, heart and lung and other organ functions:
⑨Understanding and voluntarily signing informed consent prior to performing any research-related evaluation/operation;
⑩Ability to comply with research visit schedules and other programmatic requirements.
Exclusion Criteria:
* Known hypersensitivity or delayed anaphylaxis to any agents in this trial;
* Major surgery had been performed within 4 weeks prior to the start of the study and did not fully recover;
* Have received a live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period ;
* To study the occurrence of arterial/venous thrombosis events within 6 months before medication;
* Major cardiovascular diseases;
* Is suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;
* Is suffering from an active infection that requires systemic treatment;
* History of active tuberculosis; ⑨ Positive human immunodeficiency virus (HIV) test result; ⑩ Patients with chronic hepatitis B or active hepatitis C. ⑪Conditions that the investigator believes will affect the safety or compliance of the drug therapy in this study ⑫Female/male who is pregnant or breastfeeding or who intends to give birth;Conditions3
CancerPrecision TherapySalivary Gland Carcinoma
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Actively Recruiting
PhasePhase 2
SponsorPeking Union Medical College
Started2023-08-15
Est. completion2026-07-10
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06145308