Electrocautery Resection Combined With HITHOC for Thymic Epithelial Tumors With Pleural Metastasis

N/ANot Yet RecruitingNCT07328074

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine70 enrolled

Overview

The goal of this observational study is to explore the effectiveness of electrocautery resection combined with hyperthermic intrathoracic chemotherapy (HITHOC) in patients with thymic epithelial tumors with pleural metastasis or recurrence. The study aims to: * Evaluate whether this combined treatment improves event-free survival in patients with pleural metastasis from thymic epithelial tumors * Assess the rates of grade ≥3 treatment-related adverse events * Examine how this treatment affects patients' quality of life Participants will: * Undergo extended thymectomy with electrocautery resection of pleural metastases * Receive two cycles of hyperthermic intrathoracic chemotherapy with cisplatin and doxorubicin at 42-43°C, 2-4 days apart * Complete quality of life questionnaires (EQ-5D) at baseline and regular intervals * Have regular follow-up visits with imaging and clinical assessments for up to 36 months to monitor for disease recurrence or progression

Study Type

OBSERVATIONAL

Enrollment

Conditions

Thymic Epithelial Tumor Thymoma Thymic Carcinoma Pleural Metastasis Pleural Recurrence

Patients with thymic epithelial tumors with pleural metastasis or recurrence who undergo extended thymectomy with electrocautery resection of pleural metastases followed by two cycles of hyperthermicPROCEDURE

Extended thymectomy with electrocautery ablation and resection of pleural metastases. Larger lesions (\>1cm) are thoroughly ablated with electrocautery followed by complete resection. Smaller lesions (≤1cm) that are difficult to resect are thoroughly ablated with electrocautery.

Hyperthermic Intrathoracic Chemotherapy (HITHOC)PROCEDURE

Two cycles of hyperthermic intrathoracic chemotherapy performed 2-4 days apart using BR-TRG-I device. Chemotherapy solution containing cisplatin (50 mg/m²) and doxorubicin (25 mg/m²) is circulated at 400 mL/min with inflow temperature maintained at 42-43°C for 60 minutes per cycle.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologically confirmed thymic epithelial tumor (TET) * Imaging evidence of thymic epithelial tumor with pleural dissemination or recurrence, deemed suitable for HITHOC by multidisciplinary thoracic team * Age ≥16 years and ≤80 years * American Society of Anesthesiologists (ASA) physical status classification I-II * Normal major organ function * No history of other malignancies * Prior chemotherapy completed \>4 weeks, radiotherapy \>6 weeks, immunotherapy \>6 weeks before enrollment * No allergy to cisplatin or doxorubicin * Able to understand the study content and provide informed consent Exclusion Criteria: * Evidence of extrathoracic metastasis on imaging or pathological examination * Myasthenia gravis in unstable phase or acute exacerbation * Severe systemic comorbidities, such as active infection, poorly controlled diabetes, coagulopathy, bleeding tendency, or ongoing thrombolytic/anticoagulation therapy * Positive serum pregnancy test or lactation (females) * History of organ transplantation (including autologous bone marrow transplantation and peripheral blood stem cell transplantation) * History of peripheral nervous system disease, significant psychiatric disorder, or central nervous system disease * Currently participating in other clinical trials

Outcomes

Primary Outcomes

Event-Free Survival (EFS)

Time from treatment start to first occurrence of local recurrence, distant metastasis, or death from any cause. Events are assessed through regular imaging and clinical follow-up.

Time frame: From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months

Secondary Outcomes

Incidence of Grade ≥3 Treatment-Related Adverse Events

Rate of grade ≥3 adverse events according to Clavien-Dindo classification related to surgery or chemotherapy. This includes surgical complications and chemotherapy-related toxicities.

Time frame: From treatment initiation through 30 days post-treatment

Overall Survival (OS)

Time from disease grouping to death from any cause.

Time frame: From enrollment to death from any cause, assessed up to 36 months

Quality of Life Assessed by EQ-5D

Quality of life assessed using the EuroQol 5 Dimensions (EQ-5D) questionnaire. The EQ-5D visual analog scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better quality of life.

Time frame: Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months