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

Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Neoadjuvant or Conversion Therapy; Locally Advanced or Recurrent/Metastatic Salivary Gland Carcinoma; Precision Therapy

Treatments: Drug: Nectin-4 ADC group; Drug: Ivoximab group; Drug: antiandrogen drug treatment; Drug: Apalolito vorellizumab group; Drug: HR-positive group; Drug: ESG401; Drug: albumin paclitaxel with platinum; Drug: Vedolizumab; Drug: larotinib or enttraitinib; Drug: small molecule multi-target tyrosine kinase inhibitors± Chemioterapy; Drug: Homologous Recombination repair defect group; Drug: PI3K mutant group

Study type: Interventional

Funder types: Other

Identifiers

NCT06145308

NCC4132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

10 participants in 12 patient groups

HER2 expression group

Experimental group

Description:

Vedicetumab monotherapy or combination therapy

Treatment:

Drug: Vedolizumab

NTRK gene fusion or mutant group

Experimental group

Description:

NTRK inhibitor therapy

Treatment:

Drug: larotinib or enttraitinib

AR positive group

Experimental group

Description:

Antiandrogen therapy

Treatment:

Drug: antiandrogen drug treatment

TROP-2 positive group

Experimental group

Description:

Anti-trop-2 therapy

Treatment:

Drug: ESG401

Adenoid cystadenocarcinoma group（ACCgroup）

Experimental group

Description:

Small molecule tyrosine hormone inhibitor therapy

Treatment:

Drug: small molecule multi-target tyrosine kinase inhibitors± Chemioterapy

Albumin-paclitaxe group

Experimental group

Description:

Albumin-paclitaxel combined with platinum-based chemotherapy drugs

Treatment:

Drug: albumin paclitaxel with platinum

HR-positive group

Experimental group

Description:

CDK4/6 inhibitors + aromatase inhibitors or Fluvis

Treatment:

Drug: HR-positive group

PI3K mutant group

Experimental group

Description:

PI3K inhibitors such as Apelis + Fluvis

Treatment:

Drug: PI3K mutant group

Homologous Recombination repair defect group

Experimental group

Description:

Olapalil or Nilapalil or fluzopalil or pamipalil po;

Treatment:

Drug: Homologous Recombination repair defect group

Nectin-4 ADC group

Experimental group

Description:

Veentumab ± immune checkpoint inhibitor ;

Treatment:

Drug: Nectin-4 ADC group

Ivoximab group

Experimental group

Description:

Ivoximab+ albumin paclitaxel +Cisplatin

Treatment:

Drug: Ivoximab group

Apalolito vorellizumab group

Experimental group

Description:

Apalolito vorellizumab + Platinum dual drug + bevacizumab

Treatment:

Drug: Apalolito vorellizumab group