TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma (NCT05496569) | Clinical Trial Compass
TerminatedPhase 2
TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma
Stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
China26 participantsStarted 2022-08-08
Plain-language summary
A clinical trial evaluating TQB3616 capsules versus placebo in the treatment of dedifferentiated liposarcoma. Divided into 2 stages, the second stage, a total of 118 subjects are planned to be enrolled.
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.
✓. Patients with residual disease after surgery;
✓. Local recurrence and metastatic dedifferentiated liposarcoma;
✓. Patients with disease progression confirmed by imaging results within nearly 6 months; Note: Difficult to resection by surgery: （R0：Complete tumor resection /R1：Residual tumor cells at the resection margin ）resection cannot be achieved by surgery according to the investigator's assessment: ①The tumor is huge or involves important organs; ②The tumor is located in an important vascular pathway; ③The tumor has multiple metastases, It is difficult to control by surgery; ④ Combination of serious medical diseases can cause fatal surgical risks; ⑤ Recurrence after multiple operations is not suitable for immediate surgery.
✓. Routine blood tests criteria (no blood transfusion or correction with hematopoietic stimulating factor drugs within 7 days before the examination):
✓. Hemoglobin (HGB)≥90.0g/L;
✓. Absolute neutrophil value (ANC)≥1.5×109/L;
✓. Platelet count (PLT)≥90×109/L;
Exclusion criteria
✕. Subjects with atypical lipomatous tumor/well-differentiated liposarcoma, myxoid/round cell liposarcoma, pleomorphic liposarcoma on pathology and imaging review;
✕. Have developed or currently suffers from other malignant tumors within past 3 years. The following two conditions were eligible for enrollment: Other malignancies treated with single surgery, achieving 5 consecutive years of disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor-infiltrating basement membrane)\]; Patients with other sources of carcinoma in situ and patients with previous malignancies who are currently in remission will be eligible to participate in the study if the investigator determines that the likelihood of recurrence is very low and will require sponsor approval prior to enrollment of these patients;
What they're measuring
1
Progression-free survival (PFS) assessed by an independent review committee
Timeframe: 18 to 24 months
Trial details
NCT IDNCT05496569
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
✕. Severe bone damage caused by tumor bone metastasis; including pathological fractures of weight-bearing bones (such as vertebrae, pelvis, femur, tibia, phalanges, calcaneus, etc.) and spinal cord compression that occurred within 6 months or that the investigators judged to be likely to occur in the near future;
✕. Imaging Computed Tomography or Magnetic Resonance Imaging (CT or MRI) shows the presence of tumor thrombus, brain metastasis or the number of lesions \> 10;
✕. Uncontrolled pleural effusion, pericardial effusion or ascites that still needs repeated drainage (judgment by the investigator).
✕. Received chemotherapy (including anthracyclines), radiotherapy, major surgery, biological therapy, cytokine immunotherapy, hormone therapy, clinical trial drug therapy, traditional Chinese medicine with anti-tumor indications or Chinese patent medicine, etc.
✕. Received major surgery, major surgical treatment, incisional biopsy, obvious traumatic injury within 4 weeks before the first treatment with the study drug, or has not been able to fully recover from the previous surgery as judged by the investigator, and has anti-tumor indications Chinese medicine or proprietary Chinese medicine, etc.;
✕. Previously received Abemaciclib or Palbociclib and any other CDK4/6 inhibitor treatment;