Trial Title:
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
NCT ID:
NCT06145308
Condition:
Locally Advanced or Recurrent/Metastatic Salivary Gland Carcinoma
Neoadjuvant or Conversion Therapy
Precision Therapy
Conditions: Official terms:
Carcinoma
Salivary Gland Neoplasms
Paclitaxel
Apatinib
Bicalutamide
Vedolizumab
Tyrosine Kinase Inhibitors
Androgen Antagonists
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Vedolizumab
Description:
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).
Arm group label:
HER2 expression group
Intervention type:
Drug
Intervention name:
larotinib or enttraitinib
Description:
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;
Arm group label:
NTRK gene fusion or mutant group
Intervention type:
Drug
Intervention name:
antiandrogen drug treatment
Description:
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;
Arm group label:
AR positive group
Other name:
leprerelin + bicalutamide ± Abiraterone 1000mg po qd
Intervention type:
Drug
Intervention name:
ESG401
Description:
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
Arm group label:
TROP-2 positive group
Intervention type:
Drug
Intervention name:
small molecule multi-target tyrosine kinase inhibitors± Chemioterapy
Description:
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).
Arm group label:
Adenoid cystadenocarcinoma group（ACCgroup）
Other name:
apatinib or erlotinib
Intervention type:
Drug
Intervention name:
albumin paclitaxel with platinum
Description:
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,
Arm group label:
Other group
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, etc.) and safety of precision
neoadjuvant or conversion therapy.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fei Ma
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Ma, MD
Phone:
+86-10-87787652
Email:
mafei@126.com
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Ma, Dr.
Phone:
13910217780
Email:
drmafei@126.com
Start date:
May 1, 2024
Completion date:
July 10, 2026
Lead sponsor:
Agency:
Peking Union Medical College
Agency class:
Other
Collaborator:
Agency:
Peking University Hospital of Stomatology
Agency class:
Other
Source:
Peking Union Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06145308
