Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced … (NCT04667793) | Clinical Trial Compass
UnknownPhase 2
Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial Tumor
China15 participantsStarted 2021-01-31
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.):
* 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);
* partial thromboplastin time (APTT) ≤1.5×ULN;
* total bilirubin ≤1.5×ULN;
* alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.
* 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:
* Participants who …
What they're measuring
1
Safety: frequency of severe adverse events
Timeframe: up to 5 months
2
Major pathologic response (MPR)
Timeframe: up to 4 months
Trial details
NCT IDNCT04667793
SponsorShanghai Pulmonary Hospital, Shanghai, China