Trial Title:
Neoadjuvant Treatment For Locally Advanced Thymic Cancer
NCT ID:
NCT06019468
Condition:
Thymic Carcinoma
Conditions: Official terms:
Thymoma
Thymus Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
No Masking
Intervention:
Intervention type:
Other
Intervention name:
Envolizumab combined with radiotherapy
Description:
Application of Envolizumab combined with radiotherapy for neoadjuvant treatment of
locally advanced thymic cancer. Firstly, 20-40Gy radiation therapy was administered 10-20
times. Within one week after the start of radiation therapy, Envolizumab (300 mg, D1,
Q3W, subcutaneous injection) was administered. Immunotherapy was maintained for 2-4
cycles, and surgery was performed after evaluation by the attending physician.
Arm group label:
Neoadjuvant immunotherapy combined with radiotherapy
Other name:
KN035
Summary:
The aims of this study are to verify the feasibility, effectiveness, and safety of the
combination of enrolizumab and radiotherapy for neoadjuvant treatment for locally
advanced thymic carcinoma, and to provide recommendations for the establishment of
unified evaluation criteria for the neoadjuvant therapy of thymic cancer by evaluating
the pathological remission status of thymic cancer specimens after neoadjuvant treatment.
Detailed description:
For patients with locally advanced thymic carcinoma, it is often difficult to perform
radical resection. Numerous studies have reported that neoadjuvant therapy can improve
the surgical resection rate of thymic tumors by reducing the extent of tumor invasion and
eliminating small metastatic lesions, thereby improving patient survival. However, the
efficacy of neoadjuvant immunotherapy combined with chemotherapy is limited. This study
intends to conduct a single-arm, phase II clinical trial of neoadjuvant immunotherapy
combined with radiotherapy for locally advanced thymic carcinoma to verify the
feasibility and safety of neoadjuvant immunotherapy combined with radiotherapy.
Meanwhile, the investigators evaluate the pathological remission of postoperative
specimens to provide recommendations for establishing pathological evaluation criteria
for neoadjuvant therapy for thymic carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically confirmed as thymic carcinoma;
2. Clinical staging III-IVA (TNM staging system), non-myasthenia gravis (MG) patients,
expected to undergo surgical resection;
3. On the day when the subject signs the informed consent form, they are ≥ 18 years old
and<75 years old, regardless of gender;
4. The subjects are able to understand the informed consent form, voluntarily
participate, and sign the informed consent form;
5. Subjects who have not received any anti-thymic tumor treatment in the past,
including but not limited to systemic chemotherapy, radiotherapy, or immunotherapy
(only those who have received traditional Chinese medicine treatment for anti-tumor
indications are allowed to be included, and a cleaning period of at least 2 weeks is
required);
6. At least 1 measurable lesion (according to the solid tumor efficacy evaluation
standard RECIST V1.1);
7. Physical fitness score of 0 or 1 (ECOG scoring system of the Eastern Cancer
Collaborative Group in the United States);
8. Female subjects with fertility must have a negative serum pregnancy test within 7
days before the first administration;
9. Female subjects with fertility or male subjects with partners with fertility agree
to use efficient contraceptive measures (with an annual failure rate of less than
1%) from 7 days before the first administration until 24 weeks after the end of
administration;
10. The main organ functions within 7 days before the first administration meet the
following standards:
1. Bone marrow function: hemoglobin ≥ 10.0 g/dL (no blood transfusion received
within 28 days before hemoglobin test), absolute neutrophil count ≥ 1.5 ×
109/L, platelet count ≥ 100 × 109/L (no platelet transfusion or IL-11 treatment
received within 14 days prior to platelet count test);
2. Coagulation function: INR and PT<1.5 × ULN, APTT ≤ 1.5 × ULN;
3. Liver function: transaminases (ALT and AST) ≤ 2.5 × ULN; Total bilirubin ≤ 1.5
× ULN (total bilirubin ≤ 2.5 in subjects with Gilbert's syndrome or liver
metastasis) × ULN);
4. Renal function: serum creatinine clearance rate ≥ 60 mL/min (calculated
according to Cockcroft Fault formula);
5. Adequate lung function: According to the doctor's judgment, lung function can
meet the requirements of thymectomy surgery.
Exclusion Criteria:
1. Pathologically confirmed as a thymic neuroendocrine tumor;
2. Subjects who have undergone major surgical treatment (such as abdominal or thoracic
surgery; excluding diagnostic puncture or peripheral vascular pathway replacement
surgery) or have not recovered from surgical treatment within 28 days before the
administration of this trial;
3. Within 14 days before the first administration of this study, systemic
corticosteroids (≥ 10 mg/day prednisone, or equivalent amounts of other
corticosteroids) or immunosuppressive therapy are required for 7 consecutive days;
Excluding inhalation or local application of hormones, or receiving physiological
replacement doses of hormone therapy due to adrenal insufficiency; Allow short-term
(<7 days) use of corticosteroids for prevention (such as contrast agent allergies)
or treatment of non-autoimmune diseases (such as delayed hypersensitivity reactions
caused by exposure to allergens);
4. Received live vaccines (including attenuated live vaccines) within 28 days prior to
administration in this study;
5. Previously or currently suffering from interstitial pneumonia/lung disease that
requires systemic hormone therapy;
6. Previously or currently suffering from autoimmune diseases, including but not
limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus,
sarcoidosis, Wegener syndrome (granulomatosis of vasculitis, Graves disease,
rheumatoid arthritis, pituitary inflammation, uveitis), autoimmune hepatitis,
systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (exceptions see
below), autoimmune vasculitis Autoimmune neuropathy (Guillain Barre syndrome), etc.
The following cases are excluded: type I diabetes, hypothyroidism with stable
hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid
disease), psoriasis or vitiligo without systemic treatment;
7. Other malignant tumors were combined within 5 years before the first administration,
excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle
invasive bladder cancer, localized low-risk prostate (defined as stage ≤ T2a,
Gleason score ≤ 6, and PSA ≤ 10ng/mL at the time of diagnosis of prostate cancer (if
measured, patients who have received radical treatment and have no PSA biochemical
relapse can participate in this study), and in situ cervical/breast cancer;
8. Have uncontrolled heart, kidney, gastrointestinal tract, infectious diseases and
other complications;
9. Previous history of allogeneic bone marrow or organ transplantation;;
10. Previously treated with any antibody/drug (immune checkpoint) targeting T cell
co-regulatory proteins, such as anti PD (L) 1, CTLA-4, 4-1BB, LAG 3, TIM 3, or anti
CD127; Previously received anti-tumor vaccine treatment
11. Previous history of allergic reactions to antibody-based drugs and intolerance (≥
Level 3 NCI-CTCAE V5.0); Any past history of rapid allergic reactions and
uncontrollable asthma (i.e. uncontrollable asthma symptoms of 3 or more of the 3 or
more characteristics of partially controlled asthma); Previous obvious allergies to
drugs (such as severe allergic reactions, immune-mediated hepatotoxicity,
immune-mediated thrombocytopenia or anemia);
12. Pregnant and/or lactating women;
13. Other situations that may affect the safety or compliance of drug treatment in this
study, including but not limited to mental illness, uncontrolled large amounts of
serous fluid accumulation, or subjects who require repeated drainage (recurrence
within 2 weeks after intervention) with moderate to large amounts of serous fluid
accumulation, cachexia, etc.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Deping Zhao
Email:
zdp1992@163.com
Start date:
September 4, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06019468
