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

Last updated: September 8, 2025
Sponsor: Peking Union Medical College
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Treatment

ESG401

Vedolizumab

albumin paclitaxel with platinum

Clinical Study ID

NCT06145308
NCC4132
  • Ages 18-100
  • All Genders

Study 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) and safety of precision therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with histopathologic diagnosis of salivary gland carcinoma

  • The tumor tissues were subjected to HER2/NTRK/AR/TROP-2 immunohistochemicalstaining.

  • ECOG physical status 0 or 1 score in the 3 days before the firstmedication of the study treatment;

  • Age 18 or older - no upper limit;

  • Life expectancy is more than 3 months; ⑥Have at least onemeasurable lesion according to RECIST1.1 standards; ⑦Women ofchildbearing age must have a negative pregnancy test within 7days before the first medication, and agree to receive thenecessary 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 toperforming any research-related evaluation/operation; ⑩Ability to comply with research visit schedules and otherprogrammatic requirements.

Exclusion

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 studyand did not fully recover;

  • Have received a live vaccine within 4 weeks before the start of the studyor plan to receive any vaccine during the study period ;

  • To study the occurrence of arterial/venous thrombosis events within 6months before medication;

  • Major cardiovascular diseases;

  • Is suffering from uncontrolled systemic diseases, includingdiabetes, hypertension, pulmonary fibrosis, acute lungdisease, interstitial lung disease, cirrhosis, etc.;

  • Is suffering from an active infection that requiressystemic treatment;

  • History of active tuberculosis; ⑨ Positive humanimmunodeficiency virus (HIV) test result; ⑩Patients with chronic hepatitis B or activehepatitis C. ⑪Conditions that the investigatorbelieves will affect the safety or compliance ofthe drug therapy in this study ⑫Female/male whois pregnant or breastfeeding or who intends togive birth;

Study Design

Total Participants: 39
Treatment Group(s): 33
Primary Treatment: ESG401
Phase: 2
Study Start date:
August 15, 2023
Estimated Completion Date:
July 10, 2028

Study 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 efficacy (objective response rate, etc.) and safety of neoadjuvant/conversion therapy evaluated.

To assess the efficacy of post-operative adjuvant therapy guided by minimal residual disease (MRD) testing in locally advanced salivary gland carcinoma.

Patients with locally advanced/recurrent or symptomatic, rapidly progressive metastatic salivary gland carcinoma who are intolerant of or refuse surgery and radiotherapy will be molecularly stratified and treated with precision regimens, with efficacy (objective response rate, etc.) and safety of salvage therapy evaluated.

To evaluate efficacy (objective response rate, etc.) and safety of later-line therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma.

Using multi-omic approaches to explore salivary gland carcinoma heterogeneity and biomarkers associated with recurrence, metastasis, treatment response and prognosis.

To investigate concordance between drug-sensitivity testing using ex-vivo 3D tumour models and actual clinical outcomes, and to guide later-line treatment selection based on drug-sensitivity results.

Connect with a study center

  • Fei Ma

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Fei Ma

    Beijing 1816670, Beijing Municipality 2038349 100021
    China

    Active - Recruiting

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing,
    China

    Site Not Available

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing 1816670,
    China

    Active - Recruiting

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