Nab-TET

JRCT ID: jRCTs071240019

Registered date:06/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Thymic epithelial tumors (thymoma, thymic carcinoma) with a confirmed pathological diagnosis
• Date of first enrollment: 03/07/2024
• Target sample size: 22
• Study type: Interventional

Intervention(s)

Carboplatin + nab-paclitaxel combination therapy
Carboplatin (AUC 5-6, day 1) + nab-paclitaxel (100 mg/m2, days 1, 8, 15) every 3 weeks for 4 cycles. Dosing regimen for each drug will be in accordance with the package insert. Dose setting is the responsibility of the individual center; the choice of CBDCA dose AUC 5 or 6 may be made at the discretion of the individual center's physician.

Outcome(s)

• Primary Outcome: Overall response proportion (ORP) for thymic epithelial tumor

Secondary Outcome

(1) ORP for thymoma and thymic carcinoma
(2) Overall survival (OS) for thymoma, thymic carcinoma, and thymic epithelial tumor
(3) Progression-free survival (PFS) for thymoma, thymic carcinoma, and thymic epithelial tumor
(4) Adverse event rate
(5) Quality of life

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Written consent to participate in the study has been obtained from the patient.
2) Patient is at least 18 years of age at the time consent is obtained.
3) Pathological diagnosis of thymic epithelial tumor (thymoma/thymic carcinoma) has been obtained by histological or cytological diagnosis. (Tissue classification is determined based on the WHO classification of thoracic tumor histology based on the 5th edition.)
4) Patients with unresectable clinical staging (Masaoka-Koga classification) III, IVa/b, or postoperative recurr-ence, for which chemotherapy is indicated.
5) Patients with or without measurable disease.
6) No brain metastases requiring urgent irradiation or surgery (regardless of the presence or absence of symptoms).
7) No uncontrolled pericardial effusions, pleural effusions, ascites, superior vena cava syndrome, or spinal cord compression disease. However, patients may be enrolled if they do not have a Grade 3 pleural effusion after 14 days of intrapleural infusion of talc, antimicrobial agents, or OK432 (other anticancer agents are not acceptable) after cessation of drainage.
8) Expected survival of at least 3 months from the date of initiation of treatment.
9) Patients with thymic epithelial tumors who have not received prior chemotherapy other than molecular-targeted agents or radical radiotherapy within 3 months.
10) Patients with a Performance Status (ECOG) of 0 or 1.
11) Patients with preserved major organ function such as bone marrow, liver, and kidney, and who meet the following criteria on examination within 2 weeks prior to enrollment (examination on the same day of the week 2 weeks prior to the enrollment date is acceptable)
12) Neutrophil count 1500/uL or more
13) Hemoglobin 9.0 g/dL or more
14) Platelet count 100000/uL or more
15) Total bilirubin (T-Bil) 1.8 mg/dL or less (However, if T.Bil is considered to be elevated due to constitutional jaundice, the patient is outside this limit.)
16) AST 100 IU/L or less (However, if the patient has liver metastases, AST must be less than 5 times the
upper limit of the facility standard range)
17) ALT 100IU/L or less (However, if the patient has liver metastases, this limit should be less than or equal to 5 times the upper limit of the facility's reference range.)
18) Serum creatinine (Cr) 2.0 mg/dL or less
19) SpO2 90% or more at room air (However, if SpO2 less than 90%, the patient is eligible if PaO2 60 torr or more is met.)

Exclude criteria

1) Active multiple carcinomas (synchronous multiple carcinomas and heterochronic multiple carcinomas with a disease-free interval of 2 years or less that require treatment). However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered curable by local treatment are not included.
2) Patients have infectious diseases requiring systemic treatment.
3) Patients must have an axillary temperature of 38 degrees or higher at the time of enrollment.
4) Patients with symptoms of superior vena cava syndrome requiring urgent radiotherapy.
5) Patients with poorly controlled angina (angina with onset or worsening within the last 3 weeks) or history of myocardial infarction within the last 3 months.
6) Patients with diabetes mellitus or hypertension that are difficult to control.
7) Pulmonary fibrosis evident on chest CT.
8) Grade 2 or higher peripheral neuropathy.
9) Women who are pregnant, possibly pregnant, or lactating.
10) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
11) Patients receiving continuous systemic administration of steroids or immunosuppressive drugs (infliximab, cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, tacrolimus, tocilizumab, etc.) exceeding the oral prednisolone 10 mg/day equivalent.
12) Patients with a history of severe drug allergy or hypersensitivity to therapeutic agents, polysorbate 80-containing products, or albumin. Patients who have not undergone localized in-situ irradiation within 2 weeks of enrollment.
13) HBs antigen positive.
14) HCV antibody-positive (acceptable if antiviral therapy has been completed and the patient's condition is stable).
15) HIV antibody positive (HIV antibodies may be untested).
16) Patient is participating in another clinical trial that may affect the endpoints of this study.
(Patients participating in other clinical trials must be confirmed with the study office at the time of enrollment.)
17) Other cases deemed inappropriate by the investigator.

Related Information

• Primary Sponsor: Takemoto Shinnosuke