Status:
RECRUITING
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
Lead Sponsor:
Peking Union Medical College
Collaborating Sponsors:
Peking University Hospital of Stomatology
Conditions:
Salivary Gland Carcinoma
Precision Therapy
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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...
Detailed Description
Patients with locally advanced/recurrent or oligometastatic salivary gland carcinoma will be stratified by HER2, NTRK, AR, TROP-2, etc., and receive precision-targeted or chemotherapy regimens, with e...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2028
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06145308
Start Date
August 15 2023
End Date
July 10 2028
Last Update
September 15 2025
Active Locations (2)
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1
Fei Ma
Beijing, Beijing Municipality, China, 100021
2
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China