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Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
Study Purpose
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, etc.) and safety of precision neoadjuvant or conversion therapy.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
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;Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
1. Patients with locally advanced/recurrent or oligometastatic 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, etc.) and safety of precision neoadjuvant or conversion therapy. 2. Patients with locally advanced/recurrent or metastatic salivary gland carcinoma with symptoms and rapid progression who could not tolerate or refuse surgery were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precise targeted therapy or chemotherapy to evaluate the efficacy (ORR rate, etc.) and safety of rescue therapy. 3. To explore biomarkers related to the efficacy of precision treatment of salivary gland cancer.
Arms
Experimental: HER2 expression group
Vedicetumab monotherapy or combination therapy
Experimental: NTRK gene fusion or mutant group
NTRK inhibitor therapy
Experimental: AR positive group
Antiandrogen therapy
Experimental: TROP-2 positive group
Anti-trop-2 therapy
Experimental: Adenoid cystadenocarcinoma group（ACCgroup）
Small molecule tyrosine hormone inhibitor therapy
Experimental: Other group
Albumin-paclitaxel combined with platinum-based chemotherapy drugs
Interventions
Drug: - Vedolizumab
Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma (HER2 expression group) : Vedicetumab (2.5mg/kg, Q2w) alone or combined with platinum-based chemotherapy drugs (carboplatin 200-250mg/m2, Q2w or cisplatin 50mg/m2, Q2w) Rescue therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma that cannot tolerate or refuse surgery and is rapidly progressing (HER2 expression group) : Vedicetumab monotherapy (2mg/kg, IV, Q2w) or vedicetumab (2mg/kg, IV, Q2w) combined with immune checkpoint inhibitors (triprilizumab 3mg/kg, IV, Q2w, etc.) or vedicetumab (2mg/kg, IV, Q2W, etc.) Q2w) in combination with oral HER2 TKI (pyrrotinib 400mg po qd and other drugs) or Vedicetsol in combination with platinum-based chemotherapy drugs of the doctor's choice (carboplatin 200-250mg/m2, intravenous drip, Q2w or cisplatin 50mg/m2, intravenous drip, Q2w).
Drug: - larotinib or enttraitinib
Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma (NTRK gene fusion or mutant group) : NTRK inhibitors such as larotinib 100mg Bid po or enttraitinib 600mg qd po; Rescue therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma that cannot tolerate or refuse surgery and is rapidly progressing (NTRK gene fusion or mutant group) : NTRK inhibitors such as larotinib 100mg Bid po or enttraitinib 600mg qd po;
Drug: - antiandrogen drug treatment
Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma(AR positive group) : leprerelin 3.75mg subcutaneous injection Q4w+ bicalutamide 80mg qd po ± Abiraterone 1000mg po qdor antiandrogen drug treatment; Rescue therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma that cannot tolerate or refuse surgery and is rapidly progressing(AR positive group) : leprerelin 3.75mg subcutaneous injection Q4w+ bicalutamide 80mg qd po or antiandrogen drug treatment;
Drug: - ESG401
Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma(TROP-2 positive group) : ESG401 16mg/kg,D1，D8 ,D15 ivgtt Q4w. Rescue therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma that cannot tolerate or refuse surgery and is rapidly progressing(TROP-2 positive group) : ESG401 16mg/kg,D1，D8 ,D15 ivgtt Q4w
Drug: - small molecule multi-target tyrosine kinase inhibitors± Chemioterapy
Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma(ACC group)and Rescue therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma that cannot tolerate or refuse surgery and is rapidly progressing(ACC group): Adenoid cystadenocarcinoma given acitinib (5mg bid po) or apatinib (500mg qd po) or Renvastinib (24mg qd po) or sorafenib (400mg bid po) or anrotinib (12mg qd) po) or other small molecule multi-target tyrosine kinase inhibitors± chemotherapy(albumin paclitaxel :160mg/m2 Q2w or 260mg/m2 Q3w, combined with platinum-based chemotherapy drugs of the doctor's choice: cisplatin 50mg/m2, Q2w or 75mg/m2, Q3w, or carboplatin 200-250mg/m2 Q2w or 350mg/m2 q3w, static).
Drug: - albumin paclitaxel with platinum
Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma(no target and other groups) : albumin paclitaxel :160mg/m2 Q2w or 260mg/m2 Q3w, combined with platinum-based chemotherapy drugs of the doctor's choice: cisplatin 50mg/m2, Q2w or 75mg/m2, Q3w, or carboplatin 200-250mg/m2 Q2w or 350mg/m2 q3w, ; Rescue therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma that cannot tolerate or refuse surgery and is rapidly progressing(no target and other groups) : albumin paclitaxel :160mg/m2 Q2w or 260mg/m2 Q3w, combined with platinum-based chemotherapy drugs of the doctor's choice: cisplatin 50mg/m2, Q2w or 75mg/m2, Q3w, or carboplatin 200-250mg/m2 Q2w or 350mg/m2 q3w,
Contact a Trial Team
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International Sites
Status
Recruiting
Address
Fei Ma
Beijing, Beijing, 100021
Site Contact
Fei Ma, MD
[email protected]
+86-10-87787652
Status
Recruiting
Address
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, ,
Site Contact
Fei Ma, Dr.
[email protected]
13910217780
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