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Sarcoma,Soft TissuePhase 2NCT06637007

Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma

A Phase 2 study testing Chidamide Tablets combined with AK112 in people with Sarcoma,Soft Tissue and Sarcoma, run by Shanxi Province Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Sarcoma,Soft Tissue, Sarcoma, Sarcoma of Bone
What is being tested?
Chidamide Tablets combined with AK112
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Aug 2024to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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。
  • 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；
  • 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:
  • Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);
  • Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTC ≥ 480ms), and grade ≥ 2 congestive heart failure (NYHA classification);
  • Active or uncontrolled severe infections (≥ CTC AE level 2 infection);
  • Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy;
  • Renal failure requires hemodialysis or peritoneal dialysis;
  • Individuals with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Poor control of diabetes (FBG>10mmol/L);
  • Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification>1.0 g;
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Xin Wang, Dr contact

+86 138 1117 6181

WXCAMS@126.com

Rui Wang, Dr contact

18234142488

240013861@qq.com

China1 site, 1 recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

    Xin Wang, WXCAMS@126.com

    Nianzeng Xing

    Recruiting

Other trials in China

About this study

Official title: Single Arm, Open Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma

Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.

Read the 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.

Being tested
Chidamide Tablets combined with AK112
Medical subject headings
Sarcoma, Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chidamide Tablets combined with AK112Drug

    Also called AK112

    Chidamide Tablets 30mg/day, po.Bid; AK112（10mg/kg or 20mg/kg）, ivgtt, Q3W.

Study groups in NCT06637007
Study groupRoleWhat they receive
Chidamide Tablets combined with AK112Experimental1. Medication dosage：Chidamide Tablets（30mg,Twice a week，po），AK112（Once every 3 weeks）. If you experience any discomfort during the medication process, please inform your responsible doctor in a timely manner. He/she will provide appropriate treatment based on the severity of the reaction. In severe cases, the dosage of medication will be adjusted until it is stopped. 2. Medication method: The interval between two oral doses of Xidabenzamide should not be less than 3 days (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), and should be taken 30 minutes after breakfast. During the research process and before the end of medication, the responsible doctor will conduct physical and laboratory examinations on you in accordance with the experimental protocol to evaluate the impact of the experimental drug on you.
Receives: Drug: Chidamide Tablets combined with AK112

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The efficacy of the investigational drug will be determined by the objective tumor evaluation conducted by the research center based on the RECIL 2017 lymphoma efficacy evaluation criteria

    The imaging evaluation methods for tumors are PET/CT, MR, or CT, but the evaluation methods, machines, and technical parameters should be consistent throughout the entire study period. The imaging results are interpreted by researchers or radiologists from each research center. If tumor evaluation has been conducted within 21 days before enrollment and the same methods and machines are used in the same hospital, it can be used as a baseline tumor evaluation. Baseline tumor evaluation should include the nasal cavity, chest, abdomen, pelvic cavity, and any other suspected tumor lesions. If there are clinical indications, appropriate methods can be used to examine any other known or suspected disease site, such as cranial MRI or bone scan.

    Measured: Baseline and testing every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start1 Aug 2024
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06637007
Sponsor's protocol ID
zlyygcp
Other IDs
zlyygcp
Status last verified
Oct 2024
First submitted
8 Oct 2024
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide Tablets combined with AK112 in people with Sarcoma,Soft Tissue and Sarcoma, run by Shanxi Province Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xin Wang, Dr (+86 138 1117 6181, WXCAMS@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficacy of the investigational drug will be determined by the objective tumor evaluation conducted by the research center based on the RECIL 2017 lymphoma efficacy evaluation criteria (time frame: Baseline and testing every 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06637007.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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