Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular-based Stagingcarcinoma

Sponsor

Peking Union Medical College (Other)

Overall Status

Recruiting

CT.gov ID

NCT06145308

Collaborator

Peking University Hospital of Stomatology (Other)

Enrollment

Locations

Arms

31.3

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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 the efficacy (ORR rate, etc.) and safety of precision neoadjuvant or conversion therapy.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced or Recurrent/Metastatic Salivary Gland Carcinoma Neoadjuvant or Conversion Therapy Precision Therapy	Drug: Vedolizumab Drug: larotinib or enttraitinib Drug: antiandrogen drug treatment Drug: SHR-A1921 Drug: small molecule multi-target tyrosine kinase inhibitors Drug: albumin paclitaxel with platinum	Phase 2

Detailed Description

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.
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.
To explore biomarkers related to the efficacy of precision treatment of salivary gland cancer.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Cancer Hospital, Chinese Academy of Medical Sciences/National Cancer Center of China

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jul 10, 2026

Anticipated Study Completion Date :

Jul 10, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HER2 expression group Vedicetumab monotherapy or combination therapy	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).
Experimental: NTRK gene fusion or mutant group NTRK inhibitor therapy	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;
Experimental: AR positive group Antiandrogen therapy	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 or 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; Other Names: leprerelin + bicalutamide
Experimental: TROP-2 positive group Anti-trop-2 therapy	Drug: SHR-A1921 Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma(TROP-2 positive group) : Goxatuzumab 10mg/kg, D1 and D8, Q3w or SHR-A1921 anti-TROP-2 therapy. 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) : Goxatuzumab 10mg/kg, D1 and D8, Q3w or SHR-A1921 anti-TROP-2 therapy.
Experimental: Adenoid cystadenocarcinoma group（ACCgroup） Small molecule tyrosine hormone inhibitor therapy	Drug: small molecule multi-target tyrosine kinase inhibitors Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma(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. 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. Other Names: apatinib or erlotinib
Experimental: Other group Albumin-paclitaxel combined with platinum-based chemotherapy drugs	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 combined with platinum-based chemotherapy drugs of the doctor's choice (carboplatin 200-250mg/m2, intravenous drip, Q2w or cisplatin 50mg/m2, intravenous drip, Q2w); 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 combined with platinum-based chemotherapy drugs of the doctor's choice (carboplatin 200-250mg/m2, intravenous drip, Q2w or cisplatin 50mg/m2, intravenous drip, Q2w);

Outcome Measures

Primary Outcome Measures

ORR [ORR at the end of Cycle 3 (each cycle is 14 days)]
ORR rates for neoadjuvant and translational therapy in patients with locally advanced/recurrent and advanced oligometastatic salivary gland cancer
ORR [ORR at the end of Cycle 3 (each cycle is 14 days)]
ORR rate of salvage therapy for locally advanced/recurrent or distantly metastatic salivary gland carcinoma with rapid progression that cannot tolerate or refuses surgery

Secondary Outcome Measures

MPR; [MPR rate at the end of surgical treatment]
MPR rates in patients who received neoadjuvant and translational therapy and then underwent surgery
R0 resection rate; [R0 resection rate at the end of surgical treatment]
R0 resection rate in patients who received neoadjuvant and translational therapy and then underwent surgery
Facial nerve protection rate [Facial nerve protection rate at the end of surgical treatment]
Facial nerve protection rate in patients who received neoadjuvant and translational therapy and then underwent surgery
DFS [DFS rates at 3-year]
3-year DFS rates for patients who underwent surgery
PFS; [PFS Rate at 2-Year]
2-Year PFS Rate for Patients Receiving Rescue Therapy
OS [OS rate at 5-year]
OS for all patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fei Ma	Beijing	Beijing	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