Clinical trial NCT06145308: Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
Official title: Cancer Hospital, Chinese Academy of Medical Sciences/National Cancer Center of China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Locally Advanced or Recurrent/Metastatic Salivary Gland Carcinoma
Neoadjuvant or Conversion Therapy
Precision Therapy
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
Collaborators: name: Peking University Hospital of Stomatology
First posted: 2023-11-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: ORR
timeFrame: ORR at the end of Cycle 3 (each cycle is 14 days)
measure: ORR
timeFrame: ORR at the end of Cycle 3 (each cycle is 14 days)
Secondary outcomes:
measure: MPR;
timeFrame: MPR rate at the end of surgical treatment
measure: R0 resection rate;
timeFrame: R0 resection rate at the end of surgical treatment
measure: Facial nerve protection rate
timeFrame: Facial nerve protection rate at the end of surgical treatment
measure: DFS
timeFrame: DFS rates at 3-year
measure: PFS;
timeFrame: PFS Rate at 2-Year
measure: OS
timeFrame: OS rate at 5-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fei Ma
state: Beijing
city: Beijing
country: China
facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
References: