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

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

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.

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.

The diagnostic and prognostic value of fibroblast activation protein inhibitor (FAPI) PET/CT for salivary gland cancer: All patients undergo routine standard examinations (FDG PET/CT) and FAPI PET/CT before and after treatment. Two independent blinded reading teams separately evaluate the two sets of images to provide diagnosis, staging, and follow-up on patient prognosis.

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;