Clinical trial NCT04667793: Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial Tumor
Official title: Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thymic Epithelial Tumor
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 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 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;
* Participants who have undergone major surgery or severe trauma in other systems within 2 months before the start of this trial;
* Pleural effusion, pericardial effusion or ascites that are not clinically controlled and require pleural puncture or abdominal puncture drainage within 2 weeks before inclusion;
* The patients have active pia meningioma, uncontrolled or untreated brain metastases;
* Pregnant or lactating women;
* Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
* Participated in another therapeutic clinical study;
* Other factors that researchers think it is not suitable for enrollment.

Primary outcomes:
measure: Safety: frequency of severe adverse events
timeFrame: up to 5 months
measure: Major pathologic response (MPR)
timeFrame: up to 4 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 4 months
measure: Disease-free survival (DFS)
timeFrame: up to 60 months
measure: Overall survival (OS)
timeFrame: up to 60 months
measure: Health related quality of life (HRQol)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
Study officials:
References: