Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
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 1.
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.):
The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
The patient shall sign the Informed Consent Form.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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