Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial Tumor
Overview
- Phase
- Phase 2
- Intervention
- Toripalimab + Chemotherapy
- Conditions
- Thymic Epithelial Tumor
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Major pathologic response (MPR)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Peng Zhang
Director of science and education department
Shanghai Pulmonary Hospital, Shanghai, China
Eligibility Criteria
Inclusion Criteria
- •Thymic epithelial tumor confirmed by needle biopsy;
- •No systemic metastasis confirmed by PET-CT;
- •Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or
- •At stage III-IVA (masaoka-koga) as identified by chest CT or MRI;
- •With the feasibility or anticipated feasibility after neoadjuvant therapy to receive radical surgery;
- •Aged 18-75 years;
- •At least 1 measurable lesion according to RECIST 1.1;
- •Patients with good function of other main organs (liver, kidney, blood system, etc.):
- •ANC count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L，hemoglobin ≥90 g/L;
- •the international standard ratio of prothrombin time (INR) and prothrombin time (PT) \< 1.5 times of upper limit of normal (ULN);
Exclusion Criteria
- •Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
- •Administration of any Chinese medicine against cancer before administration of the drug;
- •Participants with other cancer (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor \[including TA and tis\]) within five years before the start of this study;
- •Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
- •With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- •Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;
- •Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids \>10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted;
- •Participants who are allergic to the test drug or any auxiliary materials;
- •Participants with active hepatitis B, hepatitis C or HIV;
- •The vaccine was administered within 4 weeks of the start of the trial;
Arms & Interventions
Thymic Epithelial Tumor
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.
Intervention: Toripalimab + Chemotherapy
Outcomes
Primary Outcomes
Major pathologic response (MPR)
Time Frame: up to 4 months
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.
Safety: frequency of severe adverse events
Time Frame: up to 5 months
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.
Secondary Outcomes
- Objective response rate (ORR)(up to 4 months)
- Overall survival (OS)(up to 60 months)
- Health related quality of life (HRQol)(up to 6 months)
- Disease-free survival (DFS)(up to 60 months)