Standart Tedaviye Dirençli, KIT Exon 17 Mutasyonu Taşıyan Metastatik Gastrointestinal Stromal Tümörlerde Regorafenib ve Envafolimab Kombinasyonunun Hekim Seçimi Tedavisiyle Karşılaştırılması

Sade dilde özet

Bu çalışma, Regorafenib ile Envafolimab ilaçlarının birlikte kullanımını, KIT exon 17 mutasyonu taşıyan ve standart tedaviye dirençli metastatik gastrointestinal stromal tümör (gastrointestinal stromal tumor) hastalarında, hekimin seçtiği tedaviyle karşılaştırarak değerlendirmektedir. Çalışmaya, imatinib, sunitinib, regorafenib veya ripretinib tedavisinden sonra hastalığı ilerlemiş ya da bu tedavileri tolere edemeyen, KIT exon 17 mutasyonu bulunan 18 yaş ve üzeri hastalar alınmaktadır. Faz 2 aşamasında yürütülmektedir ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Katılımcı alıyor

Sponsor

Jian Li

Müdahale

physician-selected treatment, Regorafenib + Envafolimab

Başlangıç

14.07.2025

Tahmini bitiş

01.06.2027

Ülkeler

China

İlgili genler

Merkezler

• Beijing, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Aged ≥ 18 years, regardless of gender;
* Confirmed as gastrointestinal stromal tumor by histopathological examination;
* Having at least one measurable target lesion meeting the criteria of mRECIST v1.1 (non-lymph node lesions with a long axis ≥ 1.0 cm or a long axis ≥ the thickness of 2 slides); imaging assessment should be performed within 14 days before the first medication;
* Disease progression or intolerance after treatment with imatinib, sunitinib, regorafenib, or ripretinib;
* Primary or secondary KIT exon 17 mutation detected by genetic testing;
* Sufficient organ and bone marrow function, defined as follows: Blood routine: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 75×10⁹/L; hemoglobin (HGB) ≥ 9.0 g/dL. No use of granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion, or platelet transfusion within 14 days before the examination; Liver and kidney function: For subjects without liver metastasis, serum total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN. For subjects with liver metastasis: TBIL ≤ 1.5×ULN; ALT and AST ≤ 5×ULN. Renal function: Serum creatinine (Scr) ≤ 1.5×ULN; Sufficient coagulation function, defined as international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5×ULN; if the subject is receiving anticoagulant therapy, it is acceptable as long as PT is within the range specified for the anticoagulant drug;
* Provide 15 paraffin-embedded tissue sections before enrollment for immune microenvironment detection;
* ECOG PS score of 0-2;
* Signed informed consent form.

Exclusion Criteria:

* A history of intolerance to regorafenib treatment, or previous receipt of immune checkpoint inhibitor therapy;
* Being in pregnancy or lactation;
* Those with an expected survival period of less than 3 months;
* Those who have undergone major surgery or suffered significant trauma within 4 weeks before the first blood collection during the screening period, or are expected to require major surgery during the study period;
* Patients with current active ulcers or gastrointestinal bleeding;
* A history of interstitial lung disease or non-infectious pneumonia; a history of active tuberculosis;
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
* Patients with clinically confirmed autoimmune diseases; those with positive HIV or HCV; those with HBV-DNA exceeding the laboratory normal range; those with acute CMV infection;
* Patients with clinically confirmed central nervous system metastases;
* Patients with other malignant tumors within 5 years;
* Immunosuppressed subjects, including those with known immunodeficiency; those currently receiving systemic steroid medications (except those who have used inhaled steroids recently or currently);
* Uncontrolled hypertension: After active antihypertensive treatment, three consecutive blood pressure measurements indicate systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg;
* Subjects who, in the investigator's assessment, are unable or unwilling to comply with the requirements of the study protocol.