İleri Evre Yumurtalık Kanserinde Birinci Basamak Tedavide Disitamab Vedotin ile Carboplatin Kombinasyonunun Etkinliği ve Güvenliği

Sade dilde özet

Bu çalışma, ileri evre yumurtalık kanseri (advanced ovarian cancer), fallop tüpü kanseri ve primer periton kanseri olan hastalarda birinci basamak tedavi olarak Disitamab Vedotin (RC48) ile Carboplatin kombinasyonunun etkinliğini ve güvenliğini inceliyor. Çalışmaya, HER2 ekspresyonu (IHC 2+ veya 3+) olan, cerrahi sonrası daha önce kemoterapi almamış, evre II-IV hastalar katılabilmektedir. 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

Zhejiang Cancer Hospital

Müdahale

RC48 + Carboplatin

Başlangıç

04.01.2025

Tahmini bitiş

31.01.2028

Ülkeler

China

İlgili genler

Merkezler

• Zhejiang, China

Uygunluk kriterleri

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

Inclusion Criteria:

* Stage II-IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathological examination;
* Received the first tumor cell debulking surgery before enrollment and achieved R0 or R1 resection;
* HER2 expression: IHC 2+ or 3+;
* Had not received chemotherapy before enrollment;
* ECOG PS ≤ 2;
* Expected survival period ≥ 3 months;
* Adequate organ function. During the screening period, the following criteria should be met (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); When there is no liver metastasis, ALT and AST ≤ 2.5 × ULN, and when there is liver metastasis, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula;
* Non-pregnant women;
* Signed a written informed consent form before the trial.

Exclusion Criteria:

* Within one month prior to the start of treatment, the subject had received other anti-tumor treatments (such as radiotherapy, immunotherapy);
* The subject had central nervous system diseases or brain metastases;
* Had previously experienced grade II or above peripheral neuropathy;
* Had an uncontrolled serious disease that would affect the subject's ability to receive treatment according to the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
* Had a history of other malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma and cervical cancer);
* Had known allergies to the study-related drugs or their excipients or was intolerant to them;
* Was participating in other clinical trials at the same time;
* Subjects judged by the researcher to be unsuitable for this study.