Neoplasms

All Conditions

Blood and Lymph Conditions

Rare Diseases

Neoplasms, Glandular and Epithelial

Thymoma

Thymus Neoplasms

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Thymic Epithelial Tumor

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Cyclophosphamide

Cisplatin

Immunoglobulins

For thymoma:

Neoadjuvant treatment stage: Toripalimab 240mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Carboplatin AUC 5, Amycin 50mg/m2, Cyclophosphamide 500mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation.

Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment.

Adjuvant treatment stage: the patients who did not receive 4 cycle therapy will receive 1-2 cycles therapy up to 4 cycles in total, the following therapy is according to the NCCN guidelines.

For thymic carcinoma:

Neoadjuvant treatment stage: Toripalimab 240mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Cisplatin 50mg/m2, Paclitaxel 200mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation.

Toripalimab: 200mg, q3w, i.v., 2-4 cycles

Chemotherapy:

Thymoma: Cisplatin+Amycin+Cyclophosphamide Thymic carcinoma: Carboplatin+Paclitaxel

Toripalimab + Chemotherapy

Peng Zhang, PhD

This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of neoadjuvant Toripalimab + chemotherapy followed by radical surgery as first-line treatment in patients with locally advanced thymic epithelial tumor.

Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial Tumor

The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.

MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.

It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.

It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).

It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).

The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \& LC13, Version 3). EORTC's QLQ-C30 \& LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial Tumor	NCT04667793	Thymic Epitheli...	Toripalimab + C...	18 Years - 75 Years	Shanghai Pulmonary Hospital, Shanghai, China
Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial Tumor	NCT04667793	Thymic Epitheli...	Toripalimab + C...	18 Years - 75 Years	Shanghai Pulmonary Hospital, Shanghai, China

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