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Clinical Trials List

Protocol NumberDS8201-854
NCT Number(ClinicalTrials.gov Identfier)NCT07022483
Active

2025-11-01 - 2033-12-31

Phase III

Not yet recruiting5

ICD-10C54.1

Malignant neoplasm of endometrium

ICD-10C54.2

Malignant neoplasm of myometrium

ICD-10C54.3

Malignant neoplasm of fundus uteri

ICD-10C54.9

Malignant neoplasm of corpus uteri, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9182.0

Malignant neoplasm of corpus uteri, except isthmus

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+/2+) Endometrial Cancer (DESTINY-Endometrial02/ GOG-3122/ ENGOT-en30/GINECO)

  • Trial Applicant

     Daiichi Sankyo Taiwan Ltd. 

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Hsing Lu Division of Obstetrics & Gynecology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Peng-Hui Wang Division of Obstetrics & Gynecology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yu-Fang Huang
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator - - Division of Obstetrics & Gynecology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Endometrial Cancer

Objectives

This is a global, multicenter, open-label phase 3 trial evaluating the efficacy and safety of T-DXd versus SoC chemotherapy, with or without radiation therapy, as adjuvant therapy in participants with HER2-positive (Immunohistochemical staining [IHC] 3+/2+) endometrial cancer. Participants will be randomized 1:1 to receive either T-DXd or SoC chemotherapy as adjuvant therapy. The primary objective is to assess disease-free survival (DFS) by a blinded central independent review committee (BICR) or to confirm disease recurrence via histopathology through local assessment.

Test Drug

Frozen Crystal Injection
Injection

Active Ingredient

trastuzumab deruxtecan
CARBOPLATIN

Dosage Form

243
270

Dosage

100 mg/vial
600mg/vial

Endpoints

Disease-free survival or disease recurrence as assessed by a blinded, centrally independent evaluation committee or confirmed by local evaluation histopathology.

Inclution Criteria

Key Inclusion Criteria

Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is >18 years old)
Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology's are allowed except for sarcomas (carcinosarcomas are allowed).
Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III Note: FIGO 2023 Stage IIC includes disease with aggressive histological types with any myometrial involvement. FIGO 2023 Stage III includes disease with local and/or regional spread of the tumor of any histological subtype.
Has HER2-expression (IHC 3+/2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing.
Has adequate archived tumor tissue sample (sample from surgery is strongly recommended) available for assessment of HER2 status by central laboratory.

Exclusion Criteria

Key Exclusion Criteria

Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.
Has recurrent or FIGO 2023 Stage IV
Has measurable residual tumor after surgery as determined by BICR assessment.
Is known to have a POLE mutation from an approved and/or validated local test, according to local regulations, if available
Has a medical history of MI within 6 months before randomization/enrollment, symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above ULN at SCR (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during SCR period to rule out MI.
Has a QTcF prolongation to > 480 msec based on average of the SCR triplicate12-lead ECG. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at SCR.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    710 participants

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