Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing

Phase 2

Recruiting

• Conditions: Locally Advanced or Recurrent/Metastatic Salivary Gland Carcinoma; Precision Therapy; Neoadjuvant or Conversion Therapy
• Interventions: Drug: albumin paclitaxel with platinum; Drug: antiandrogen drug treatment; Drug: ESG401; Drug: Vedolizumab; Drug: larotinib or enttraitinib; Drug: small molecule multi-target tyrosine kinase inhibitors± Chemioterapy; Drug: HR-positive group; Drug: PI3K mutant group; Drug: Homologous Recombination repair defect group; Drug: Nectin-4 ADC group; Drug: Ivoximab group; Drug: Apalolito vorellizumab group

• Registration Number: NCT06145308
• Lead Sponsor: Peking Union Medical College

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.

Detailed Description

1. Patients with locally advanced/recurrent or oligometastatic salivary carcinoma are divided into groups based on HER2, NTRK, AR, TROP-2, etc. for precision targeted therapy or chemotherapy, and the efficacy (ORR rate, etc.) and safety of precision neoadjuvant or transformative treatment are evaluated.

2. Patients with locally advanced/recurrent or symptomatic, rapidly progressive metastatic salivary carcinoma who cannot tolerate or refuse surgery and radiotherapy are divided into groups based on HER2, NTRK, AR, TROP-2, etc. for precision treatment, and the efficacy (ORR rate, etc.) and safety of salvage treatment are evaluated.

3. The efficacy (ORR rate, etc.) and safety of post-line treatment for locally advanced/recurrent or distant metastatic salivary carcinoma.

4. Multi-omics technology explores the heterogeneity of salivary carcinoma and the biomarkers related to recurrence, metastasis, efficacy, and prognosis.

5. The consistency between the drug sensitivity detection in ex vivo 3D tumor models and the actual clinical efficacy of salivary carcinoma is studied, and the sensitive schemes selected based on the results of the drug sensitivity experiments are used to guide the post-line treatment of salivary carcinoma.

Study Timeline

• Study Start: 2023-08-15
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-07-10
• Study Completion: 2026-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin-paclitaxe group	albumin paclitaxel with platinum	Albumin-paclitaxel combined with platinum-based chemotherapy drugs
AR positive group	antiandrogen drug treatment	Antiandrogen therapy
TROP-2 positive group	ESG401	Anti-trop-2 therapy
HER2 expression group	Vedolizumab	Vedicetumab monotherapy or combination therapy
NTRK gene fusion or mutant group	larotinib or enttraitinib	NTRK inhibitor therapy
Adenoid cystadenocarcinoma group（ACCgroup）	small molecule multi-target tyrosine kinase inhibitors± Chemioterapy	Small molecule tyrosine hormone inhibitor therapy
HR-positive group	HR-positive group	CDK4/6 inhibitors + aromatase inhibitors or Fluvis
PI3K mutant group	PI3K mutant group	PI3K inhibitors such as Apelis + Fluvis
Homologous Recombination repair defect group	Homologous Recombination repair defect group	Olapalil or Nilapalil or fluzopalil or pamipalil po;
Nectin-4 ADC group	Nectin-4 ADC group	Veentumab ± immune checkpoint inhibitor ;
Ivoximab group	Ivoximab group	Ivoximab+ albumin paclitaxel +Cisplatin
Apalolito vorellizumab group	Apalolito vorellizumab group	Apalolito vorellizumab + Platinum dual drug + bevacizumab

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
DFS	DFS rates at 3-year	3-year DFS rates for patients who underwent surgery
OS	OS rate at 5-year	OS for all patients
MPR;	MPR rate at the end of surgical treatment	MPR rates 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
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
PFS;	PFS Rate at 2-Year	2-Year PFS Rate for Patients Receiving Rescue Therapy

Trial Locations

Locations (2)

Fei Ma; 🇨🇳 Beijing, Beijing, China

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China