Trial Title:
Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma
NCT ID:
NCT06637007
Condition:
Sarcoma,Soft Tissue
Sarcoma
Sarcoma of Bone
Conditions: Official terms:
Sarcoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide Tablets combined with AK112
Description:
Chidamide Tablets 30mg/day, po.Bid; AK112（10mg/kg or 20mg/kg）, ivgtt, Q3W.
Arm group label:
Chidamide Tablets combined with AK112
Other name:
AK112
Summary:
Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced
bone and soft tissue sarcoma of second-line and above.
Detailed description:
Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced
bone and soft tissue sarcoma of second-line and above.
Main objective: To explore the objective response rate (ORR) and progression free
survival (PFS) of Xidabenzamide combined with AK112 for disease stability in advanced
bone and soft tissue sarcoma of second-line and above Secondary objective: To explore the
overall survival (OS), quality of life (QOL), safety, and tolerability indicators of
Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of
second-line and above.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The patient voluntarily participated in this study and signed an informed consent
form；
- All advanced bone and soft tissue sarcomas diagnosed by pathology have at least one
measurable lesion according to RECIST 1.1 criteria, mainly including synovial
sarcoma, smooth muscle sarcoma, vascular sarcoma, undifferentiated pleomorphic
sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell
sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor,
undifferentiated sarcoma, rhabdomyosarcoma, protuberant skin fibrosarcoma, Ewing's
sarcoma/primary neuroectodermal tumor, connective tissue proliferative small round
cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroadenoma,
chondrosarcoma, osteosarcoma. Except for the following types: malignant
mesothelioma, acinar soft tissue sarcoma, gastrointestinal stromal tumor, and extra
bone mucinous chondrosarcoma;
- Patients with advanced bone and soft tissue sarcoma who experience disease
progression or failure after first-line standard treatment;
- 18~75 years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3
months;
- Adequate organ and bone marrow function, no severe hematopoietic dysfunction, heart,
lung, liver, kidney, thyroid dysfunction, or immunodeficiency (no blood transfusion,
granulocyte colony-stimulating factor, or other related medical support received
within 14 days prior to the use of the study drug)；
- The main organ function meets the following criteria within 7 days before treatment:
1. Blood routine examination standard (without blood transfusion within 14 days)：
- hemoglobin（HB）≥90g/L；
- Absolute Neutrophil Count（ANC）≥1.5×109/L；
- platelet（PLT）≥80×109/L。
2. Biochemical tests must meet the following standards：
- total bilirubin（TBIL）≤1.5 upper limit of normal (ULN) ；
- Alanineaminotransferase（ALT）and Aspartic transaminaseAST≤2.5 ULN，If
accompanied by liver metastasis, ALT and AST≤5 ULN；
- Serum creatinine（SCr）≤1.5 ULN or Creatinine clearance
rate(CCr)≥60ml/min；
3. Doppler ultrasound evaluation：Left ventricular ejection fraction (LVEF) ≥ Low
limit of normal (50%)。
- Thyroid Stimulating Hormone（TSH）or Free Thyroxine（FT4）or Free
triiodothyronine（FT3）all within the normal range of ± 10%.
- Women of childbearing age should agree to use contraceptive measures (such as
intrauterine devices, birth control pills, or condoms) during the study period and
within 6 months after the end of the study; Serum or urine pregnancy test negative
within 7 days prior to enrollment in the study, and must be non lactating.
- patient; Men should agree to patients who must use contraception during the study
period and within 6 months after the end of the study period.
Exclusion criteria: Patients with any of the following conditions will not be included in
this study
- Patients who have previously used sildenafil or other histone deacetylase
inhibitors;
- Previously received treatment with immune checkpoint inhibitors (PD-1, PD-L1,
CTLA-4, etc.);
- Other malignant tumors that have occurred or are currently present within the past 5
years, except for cured cervical carcinoma in situ, non melanoma skin cancer, and
superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1
(tumor infiltrating basement membrane)];
- Received systemic anti-tumor therapy, including chemotherapy, immunotherapy, and
biological therapy (such as tumor vaccines, cytokines, or growth factors that
control cancer), within 28 days before starting the research treatment;
- Have received Chinese herbal medicine or traditional Chinese patent medicines and
simple preparations with anti-tumor indications within 7 days before starting the
research treatment;
- Planned systemic anti-tumor therapy within 4 weeks prior to enrollment or during the
study medication period, including cytotoxic therapy, signal transduction
inhibitors, immunotherapy (or use of mitomycin C within 6 weeks prior to receiving
experimental drug treatment). Expanded field radiation therapy (EF-RT) was performed
within 4 weeks prior to enrollment, or limited field radiation therapy was performed
within 2 weeks prior to grouping to assess tumor lesions;
- Accompanied by pleural effusion or ascites, causing respiratory syndrome (≥ CTC AE
grade 2 respiratory distress [grade 2 respiratory distress refers to shortness of
breath during light activity; affects instrumental daily activities]);
- Unrelieved toxic reactions above CTC AE (4.01) grade 1 caused by any previous
treatment, excluding hair loss;
- Patients with brain metastases accompanied by symptoms or symptom control time less
than 2 months;
- Patients with any severe and/or uncontrolled illnesses, including:
1. Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg,
diastolic blood pressure ≥ 100 mmHg);
2. Suffering from grade I or above myocardial ischemia or myocardial infarction,
arrhythmia (including QTC ≥ 480ms), and grade ≥ 2 congestive heart failure
(NYHA classification);
3. Active or uncontrolled severe infections (≥ CTC AE level 2 infection);
4. Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis
require antiviral therapy;
5. Renal failure requires hemodialysis or peritoneal dialysis;
6. Individuals with a history of immunodeficiency, including HIV positivity or
other acquired or congenital immunodeficiency diseases, or a history of organ
transplantation;
7. Poor control of diabetes (FBG>10mmol/L);
8. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein
quantification>1.0 g;
9. Patients with epileptic seizures who require treatment;
- Received major surgical treatment, open biopsy, or significant traumatic injury
within 28 days prior to enrollment;
- Patients with any signs or medical history of bleeding, regardless of the severity;
Patients who have experienced any bleeding or bleeding events ≥ CTCAE grade 3 within
the first 4 weeks of enrollment, with unhealed wounds, ulcers, or fractures;
- Individuals who have experienced arterial/venous thrombotic events within the past 6
months, such as cerebrovascular accidents (including temporary ischemic attacks),
deep vein thrombosis, and pulmonary embolism;
- Patients with active ulcers, intestinal perforation, and intestinal obstruction;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or
have mental disorders;
- Participated in clinical trials of other anti-tumor drugs within 28 days prior to
enrollment;
- According to the researchers' judgment, there are accompanying diseases that
seriously endanger patient safety or affect the completion of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Wang
Email:
WXCAMS@126.com
Investigator:
Last name:
Nianzeng Xing
Email:
Principal Investigator
Start date:
August 1, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shanxi Province Cancer Hospital
Agency class:
Other
Source:
Shanxi Province Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06637007
